Treatment of Pediatric Diaphyseal Femur Fractures Evidence-Based Clinical Practice Guideline

TREATMENT OF PEDIATRIC DIAPHYSEAL FEMUR FRACTURES EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE

Adopted by the American Academy of Orthopaedic Surgeons Board of Directors

June 12, 2015

2015 REPORT FOR THE REISSUE OF THE 2009 CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF PEDIATRIC DIAPHYSEAL FEMUR FRACTURES

“This guideline is greater than 5 years old and is reviewed every five years. New studies have been published since this guideline was developed, however the AAOS has determined that these studies are not sufficient to warrant changing the guideline at this time. The information contained in this guideline provides the user with the best evidence available at the time this guideline was published.”

OVERVIEW OF 2015 UPDATES TO THE 2009 ORIGINAL GUIDELINE 1) Addition of the Shemshaki, et al, 2011 study findings to Elastic Intramedullary Nails. 2) Updated strength of recommendation language to match current AAOS guideline language (see Grading the Recommendations). 3) Removed “inconclusive” recommendations due to lack of evidence (see Appendix XI)

For a user-friendly version of this clinical practice guideline, please visit the AAOS OrthoGuidelines Web-Based App at: http://www.orthoguidelines.org

AAOS v 1.0 061909 Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances.

Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines.

Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document.

FDA Clearance Some drugs or medical devices referenced or described in this Clinical Practice Guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.

Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS.

I. SUMMARY OF RECOMMENDATIONS The original guideline on the Treatment of Pediatric Diaphyseal Femur Fractures (PDFF) was the third guideline developed by the AAOS in-house. It had fourteen recommendations of varying strengths. However, per current AAOS policy, all recommendations in the original guideline identified as “inconclusive” were removed from this 2015 reissue (see Appendix XI for a full list of the inconclusive recommendations that were removed). Based on the current procedure for updating AAOS guidelines, the Medical Librarian ran a preliminary search to identify literature that could address and possibly change the original recommendations. The AAOS Evidence-Based Medicine Unit then used the inclusion criteria from the original guideline to determine if any articles published after the final literature search date of the original guideline were relevant to the original recommendations.

The following is a summary of the recommendations in the AAOS’ clinical practice guideline on the Treatment of Pediatric Diaphyseal Femur Fractures (PDFF). This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will also see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone.

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Strength of Recommendation Descriptions

Overall Strength of Strength Evidence Description of Evidence Strength Strength Visual Evidence from two or more “High” strength studies with consistent findings Strong Strong for recommending for or against the intervention. Evidence from two or more “Moderate” strength studies with consistent findings, Moderate Moderate or evidence from a single “High” quality study for recommending for or against the intervention. Evidence from two or more “Low” strength studies with consistent findings Low Strength or evidence from a single study for Evidence or recommending for or against the Limited Conflicting intervention or diagnostic test or the Evidence evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention. There is no supporting evidence. In the absence of reliable evidence, the work group is making a recommendation based on their clinical opinion. Consensus* No Evidence Consensus recommendations can only be created when not establishing a recommendation could have catastrophic consequences.

CHILD ABUSE Strong evidence supports that children younger than thirty-six months with a diaphyseal femur fracture be evaluated for child abuse. Grade of Recommendation: Strong

INFANT FEMUR FRACTURE Limited evidence supports treatment with a Pavlik harness or a spica cast for infants six months and younger with a diaphyseal femur fracture, because their outcomes are similar. Grade of Recommendation: Limited

EARLY OR DELAYED SPICA CASTING Moderate evidence supports early spica casting or traction with delayed spica casting for children age six months to five years with a diaphyseal femur fracture with less than 2 cm of shortening.

Grade of Recommendation: Moderate

ELASTIC INTRAMEDULLARY NAILS Limited evidence supports the option for physicians to use flexible intramedullary nailing to treat children age five to eleven years diagnosed with diaphyseal femur fractures.

Grade of Recommendation: Limited

ORIF PEDIATRIC FEMUR FRACTURES Limited evidence supports rigid trochanteric entry nailing, submuscular plating, and flexible intramedullary nailing as treatment options for children age eleven years to skeletal maturity diagnosed with diaphyseal femur fractures, but piriformis or near piriformis entry rigid nailing are not treatment options. Grade of Recommendation: Limited

PAIN CONTROL Limited evidence supports regional pain management for patient comfort peri- operatively. Grade of Recommendation: Limited

WATERPROOF CASTING Limited evidence supports waterproof cast liners for spica casts are an option for use in children diagnosed with pediatric diaphyseal femur fractures.

Grade of Recommendation: Limited

2015 GUIDELINE REISSUE WORK GROUP

Chair, AAOS Evidence-Based Quality and Value Committee: David S. Jevsevar, MD, MBA Vice Chair, Orthopaedics, Assistant Professor of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center 1 Medical Center Drive Lebanon, NH 03756 Phone 630-650-5133

Guidelines Oversight Leader, AAOS Evidence-Based Quality and Value Committee: Kevin Shea, MD Intermountain Orthopaedics 600 N. Robbins Rd Ste 400 Boise, ID 83702

AAOS Staff (2015 Guideline Reissue)

William Shaffer, MD AAOS Medical Director

Deborah Cummins, PhD Director, Department of Research and Scientific Affairs

Jayson Murray, MA Manager, Evidence-Based Medicine Unit

Ben Brenton, MPH Research Analyst, Evidence-Based Medicine Unit

Anne Woznica AAOS Medical Librarian

Kaitlyn Sevarino Evidence-Based Quality and Value (EBQV) Coordinator

Erica Linskey Administrative Assistant, Evidence-Based Medicine Unit

2007 GUIDELINE WORK GROUP

Mininder S. Kocher, MD, MPH, Boston, MA 02115 Chair Children's Hospital James O Sanders, MD 300 Longwood Ave Department of Orthopaedics Orthopaedic Dept Rehabilitation University of Rochester Boston, MA 02115 601 Elmwood Avenue Rochester NY 14642 Ernest L. Sink, MD, Co-Chair The Children's Hospital Guidelines Oversight Chair: 13123 East 16th Ave B060 Aurora, CO 80045 William C. Watters, III MD 6624 Fannin #2600 R Dale Blasier, MD Houston, TX 77030 Dept of Orthopaedic Surgery 800 Marshall St Sturgis 363 Guidelines Oversight Vice-Chair: Little Rock, AR 72202 Michael J. Goldberg MD Scott J. Luhmann, MD Children’s Hospital and Regional St Louis Children's Hospital Medical Ctr. One Children's Pl Ste 4S 20 4800 Sand Point Way NE #w7706 Saint Louis, MO 63110 PO Box 5371 Seattle WA 98105-5371 Charles T. Mehlman, DO, MPH Children's Hospital Medical Center Evidence-Based Practice Committee 3333 Burnet Avenue, MLC 2017 Chair: Cincinnati, Ohio 45229-3039 Michael Warren Keith, MD David M. Scher, MD 2500 Metro Health Drive Hospital for Special Surgery Cleveland, OH 44109-1900 535 E 70th St 5th Fl New York, NY 10021

Travis Matheney, MD Children's Hospital Boston Orthopedic Surgery 47 Joy Street

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Former AAOS Staff (2007 Guideline)

Robert H. Haralson III, MD, MBA Charles M. Turkelson, PhD Janet L. Wies, MPH Patrick Sluka, MPH Kristin Hitchcock

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Table of Contents

2015 Report for the ReIssue of the 2009 Clinical Practice Guideline on the Treatment of Pediatric Diaphyseal Femur Fractures ...... i

Overview of 2015 updates to the 2009 original guideline ...... i

I. SUMMARY OF RECOMMENDATIONS ...... III

Child Abuse ...... v

Infant Femur Fracture ...... v

Early or Delayed Spica Casting ...... v

Elastic Intramedullary Nails...... v

ORIF Pediatric Femur Fractures ...... v

Pain Control ...... v

Waterproof Casting ...... v

2015 Guideline Reissue Work Group ...... vi

2007 Guideline Work Group ...... vii

TABLE OF CONTENTS ...... IX

LIST OF TABLES ...... XII

LIST OF FIGURES ...... XII

II. INTRODUCTION ...... 1

Overview...... 1

Goals and Rationale ...... 1

Intended Users ...... 1

Patient Population ...... 2

Incidence ...... 2

Prevalence ...... 2

Burden of Disease ...... 2

Etiology ...... 2

Risk Factors ...... 2

Emotional and Physical Impact of Pediatric Diaphyseal Femur Fractures ...... 3

Potential Benefits, Harms, And Contraindications ...... 3

III. METHODS ...... 4

Guideline Reissue ...... 4

Preliminary Recommendations ...... 4

Study Selection Criteria ...... 5 Types of Studies ...... 5

Original and Updated Literature Searches ...... 6 Search for RCTs and other study designs ...... 7

Data Extraction ...... 7

Grading the Recommendations ...... 8

Statistical Methods ...... 9

Peer Review ...... 9

Public Commentary...... 9

The AAOS Guideline Approval Process ...... 10

Revision Plans ...... 10

Guideline Dissemination Plans ...... 10

IV. RECOMMENDATIONS AND SUPPORTING DATA ...... 11

Child Abuse ...... 11 Rationale ...... 11 Supporting Evidence ...... 12

Infant Femur Fracture ...... 13 Rationale ...... 13 Supporting Evidence ...... 13

Early or Delayed Spica Casting ...... 15 Rationale ...... 15 Supporting Evidence ...... 15 Previously Published Systematic Reviews ...... 19

Elastic Intramedullary Nails...... 20 Rationale ...... 20 Supporting Evidence ...... 21 Previously Published Systematic Reviews ...... 45

ORIF Pediatric Femur Fractures ...... 46 Rationale ...... 46 Supporting Evidence ...... 46 Previously Published Systematic Reviews ...... 51

Pain Control ...... 52 Rationale ...... 52 Supporting Evidence ...... 52 Previously Published Systematic Reviews ...... 55

Waterproof Casting ...... 56 Rationale ...... 56 Supporting Evidence ...... 56

Future Research ...... 57

V. APPENDIXES ...... 59

Appendix I ...... 60 AAOS Bodies That Approved the 2015 Guideline Reissue ...... 60 Appendix II ...... 61 Literature Searches ...... 61 General Search ...... 61 Waterproof Cast Liner Search ...... 62

Appendix III ...... 63 Study Attrition Flowcharts ...... 63 Original 2008 Literature Search Flowchart ...... 63 Updated 2013 Literature Search Flowchart ...... 63 Waterproof Cast Liner Search Flowchart ...... 64

Appendix IV ...... 65 Data Extraction Elements ...... 65

Appendix V ...... 66 Form for Assigning Grade of Recommendation (Interventions) ...... 66

Appendix VI ...... 68 Peer Review Panel for the Original 2009 Guideline ...... 68 Public Commentary for Original 2009 Guideline ...... 69

Appendix VII ...... 70 Structured Peer Review Form ...... 70

Appendix VIII ...... 73 Interpreting the Forest Plots49 ...... 73 Description of Symbols Used in Figures and Tables ...... 74

Appendix IX ...... 75 Conflict of Interest ...... 75 AAOS Disclosure Program Information ...... 75

Appendix X ...... 77 References ...... 77 Included Articles ...... 81

Excluded Articles from Original Search ...... 84 Excluded Articles from Updated Search ...... 101

Appendix XI ...... 102 Inconclusive Recommendations Removed from Updated Guideline ...... 102

List of Tables Table 1. Grade of Recommendation Description ...... 8 Table 2 AAOS Guideline Language ...... 9 Table 3. Incidence of Diaphyseal Femur Fractures Caused by Child Abuse ...... 12 Table 4. Summary of Evidence ...... 16 Table 5. Summary of Updated Findings for Titanium Elastic Nailing ...... 21 Table 6. Flexible Intramedullary Nailing and Patients’ Weight ...... 22 Table 7. Summary of Significant Outcomes with Level of Evidence ...... 23 Table 8. Summary of Nonsignificant Outcomes with Level of Evidence ...... 24 Table 9. Summary of High Quality Evidence ...... 27 Table 10. Summary of Moderate Quality Evidence ...... 28 Table 11. Summary of Low Quality Evidence ...... 30 Table 12. Flexible Intramedullary Nailing and Patients’ Weight ...... 47 Table 13. Traction vs. Piriformis Entry Rigid Nailing (Herndon et al.39) ...... 47 Table 14. Rigid Trochanteric Entry Nailing Outcomes (Kanellopoulos et al.40) ...... 48 Table 15. Rigid Near Piriformis Entry Nailing Outcomes (Buford et al.38) ...... 49 Table 16. Bridge Plating Outcomes (Agus et al.41) ...... 49 Table 17. Femoral Nerve Block Complications ...... 54

List of Figures Figure 1. Incidence of Diaphyseal Femur Fractures Caused by Child Abuse ...... 12 Figure 2. Pavlik Harness vs. Spica Cast ...... 14 Figure 3. Time Immobilized (Time to Union) ...... 17 Figure 4. Shortening...... 17 Figure 5. Angulation ...... 18 Figure 6. Bowing ...... 18 Figure 7. Complications ...... 19 Figure 8. External Fixation vs. Spica Cast - binary outcomes (Wright et al.22) ...... 33 Figure 9. External Fixation vs. Spica Cast -continuous outcomes (Wright et al.22) ...... 33 Figure 10. External Fixation vs. Spica Cast - Complications (Wright et al.22) ...... 34 Figure 11. Dynamic vs. Static External Fixation (Domb et al.28) ...... 34 Figure 12. Traction & Cast vs. Flexible Nails –binary outcomes ...... 35 Figure 13. Traction & Cast vs. Flexible Nails – continuous outcomes ...... 35 Figure 14. Traction & Cast vs. Flexible Nails - Complications ...... 36 Figure 15. Early Spica Cast vs. Traction - continuous outcomes (Ali et al.30) ...... 36 Figure 16. Early Spica Cast vs. Traction -Complications (Ali et al.30) ...... 37 Figure 17. Early Pontoon Spica vs. Traction/Cast – Short-term Complications (Curtis et al.31) ...... 37 Figure 18. External Fixation vs. Traction & Cast - Treatment Length (Nork et al.32) ..... 38

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Figure 19. External Fixation vs. Traction & Cast – Complications (Nork et al.32) ...... 38 Figure 20. External Fixation vs. Traction - Treatment Length (Hedin et al.34) ...... 39 Figure 21. External Fixation vs. Traction - Patient Satisfaction (Hedin et al.34) ...... 39 Figure 22. Flexible Nails vs. Traction & Cast - binary outcomes ...... 40 Figure 23. Flexible Nails vs. Traction & Cast -Leg Length Discrepancy (Song et al.33) . 40 Figure 24. Flexible Nails vs. Traction & Cast - Major Complications ...... 41 Figure 25. Flexible Nails vs. Traction & Cast - Minor Complications...... 41 Figure 26. Titanium vs. Stainless Steel Flexible Nails – Complications (Wall et al.37) ... 42 Figure 27. Immediate vs. Delayed Spica Cast - Complications (Rasit et al.35) ...... 42 Figure 28. Early Intervention vs. Traction (Sturdee et al.36) ...... 43 Figure 29. Flexible Nailing vs. External Fixation - Continuous Outcomes (Barlas et al. 200626)...... 43 Figure 30. Flexible Nailing vs. External Fixation -Binary Outcomes (Barlas et al. 200626) ...... 44 Figure 31. Flexible Nailing vs. External Fixation - Complications(Barlas et al. 200626) . 44 Figure 32. Titanium Elastic Nailing Outcomes Among Age 11+ (Moroz et al.27) ...... 48 Figure 33. Bridge Plating - Percentage of Patients with Frontal Plane Angulation (Agus et al.41) ...... 50 Figure 34. Bridge Plating -Percentage of Patients with Sagittal Plane Angulation (Agus et al.41) ...... 50 Figure 35. Hematoma Block vs. Control - Time until First Post-Operative Narcotic Dose ...... 53 Figure 36. Hematoma Block vs. Control - Post-Operative Narcotic Requirement ...... 53 Figure 37. Hematoma Block vs. Control - Binary Outcomes ...... 54 Figure 38. Femoral Nerve Block – Pain Relief ...... 54 Figure 39. Waterproof Liner vs. No Waterproof Liner ...... 57

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II. INTRODUCTION OVERVIEW This clinical practice guideline presents the results of a systematic review of published studies on the treatment of isolated diaphyseal femur fractures in children, where children are defined as those not having reached skeletal maturity. In addition to providing practice recommendations, this guideline also highlights gaps in the literature and areas that require future research.

This guideline is intended to be used by all appropriately trained surgeons and all qualified physicians considering treatment of isolated diaphyseal femur fractures in children. It is also intended to serve as an information resource for decision makers and developers of practice guidelines and recommendations.

GOALS AND RATIONALE The purpose of this clinical practice guideline is to help improve treatment based on the current best evidence. Current evidence-based practice (EBP) standards demand that physicians use the best available evidence in their clinical decision making. To assist in this decision making, this clinical practice guideline consists of a systematic review of the available literature on the treatment of isolated diaphyseal femur fractures in children. The systematic review detailed herein includes evidence published from 1966 through October 1, 2008 and demonstrates where there is good evidence, where evidence is lacking, and what topics future research must target in order to improve the treatment of children with isolated diaphyseal femur fractures. AAOS staff and the Pediatric Diaphyseal Femur Fractures physician work group systematically reviewed the available literature and subsequently wrote the following recommendations based on a rigorous, standardized process.

Musculoskeletal care is provided in many different settings by many different providers. We created this guideline as an educational tool to guide qualified physicians through a series of treatment decisions in an effort to improve the quality and efficiency of care. This guideline should not be construed as including all proper methods of care or excluding methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment must be made in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution.

INTENDED USERS This guideline is intended to be used by orthopaedic surgeons and all qualified physicians managing pediatric patients. Typically, orthopaedic surgeons will have completed medical training, a qualified residency in orthopaedic surgery, and some may have completed additional sub-specialty training. Insurance payers, governmental bodies, and health-policy decision-makers may also find this guideline useful as an evolving standard of evidence regarding treatment of diaphyseal femur fractures in pediatric patients.

Treatment of pediatric diaphyseal femur fractures is based on the assumption that decisions are predicated on guardian and physician mutual communication with

discussion of available treatments and procedures applicable to the individual patient. Once the patient’s guardian has been informed of available therapies and has discussed these options with his/her child’s physician, an informed decision can be made. Clinician input based on experience with both conservative management and surgical skills increases the probability of identifying patients who will benefit from specific treatment options.

PATIENT POPULATION This document addresses the treatment of isolated diaphyseal femur fractures in children who have not yet reached skeletal maturity. The guideline provides information on pediatric patient management after diagnosis of a diaphyseal femur fracture. This guideline is not intended for use in pediatric patients who present with additional coexisting injuries that require formal surgical intervention or other life-threatening conditions that take precedence over the treatment of the diaphyseal femur fracture.

INCIDENCE The annual rate of children who present with femoral shaft fracture has been estimated at 19 per 100,000.1 Boys have a higher risk of fracture than girls and this is consistent with participation of boys in sporting activites.1,2

PREVALENCE Diaphyseal femur fractures account for 1.4%3 to 1.7%4 of all pediatric fractures.

BURDEN OF DISEASE There are many components to consider when calculating the overall cost of treatment for pediatric femoral fracture.5 The main considerations for patients and third party payers are the relative cost and effectiveness of each treatment option. But hidden costs for pediatric patients must also be considered. These costs include the additional home care required for a patient, the costs of rehabilitation and of missed school for the patient, child care costs if both parents work, and time off of work required by one or both parents to care for the pediatric patient.6

ETIOLOGY The primary cause of diaphyseal femur fracture in children varies by age groups but includes falls, motor-vehicle accidents, and sports injuries.1 In addition, the Cincinnati Children’s Hospital Medical Center states, “In children less than one year of age, child abuse is the leading cause of femoral fractures and abuse remains a significant concern in toddlers up to about five years of age.”7

RISK FACTORS Occurrences of pediatric diaphyseal femur fractures are higher in boys than in girls in all age groups.1,2 This literature also suggests that the primary mechanism of fracture is age- related, including falls and child abuse for younger children, falls, motor vehicle- pedestrian, bicycle, and motor-vehicle collisions for school age children and motor- vehicle or sports related accidents in teenagers.

One study suggests increased risk of fracture for blacks over whites1 and one study suggests no difference by race/ethnicity.2 Both studies suggest that lower socioeconomic conditions also increase fracture risk.

EMOTIONAL AND PHYSICAL IMPACT OF PEDIATRIC DIAPHYSEAL FEMUR FRACTURES The prolonged loss of mobility and absence from school often associated with the treatment of pediatric diaphyseal femur fractures can lead to adverse physical, social, and emotional consequences for the child as well as the child’s family. Treatments that minimize the child’s length of immobilization and time out of school are therefore desirable.

POTENTIAL BENEFITS, HARMS, AND CONTRAINDICATIONS Invasive and operative treatments are associated with known risks. Contraindications vary widely based on the treatment administered. Therefore, discussion of available treatments and procedures applicable to the individual patient rely on mutual communication between the patient’s guardian and physician, weighing the potential risks and benefits for that patient.

Further, the age groups referred to in the specific recommendations are general guides. Obviously, additional factors may affect the physician’s choice of treatment including but not limited to associated injuries the patient may present with as well as the individual’s comorbidities, skeletal maturity, and/or specific patient characteristics including obesity. The individual patient’s family dynamic will also influence treatment decisions; therefore, treatment decisions made for children who border any age group should be made on the basis of the individual. Decisions will always need to be predicated on guardian and physician communication with discussion of available treatments and procedures applicable to the individual patient. Once the patient’s guardian has been informed of available therapies and has discussed these options with his/her child’s physician, an informed decision can be made. Clinician input based on experience increases the probability of identifying patients who will benefit from specific treatment options.

III. METHODS This clinical practice guideline and the systematic review upon which it is based evaluate the effectiveness of treatments for isolated pediatric diaphyseal femur fractures. This section describes the methods used to prepare this guideline and systematic review, including search strategies used to identify literature, criteria for selecting eligible articles, grading the evidence, data extraction, methods of statistical analysis, and the review and approval of the guideline. The methods used to perform this systematic review were employed to minimize bias in the selection and summary of the available evidence.8,9 These processes are vital to the development of reliable, transparent, and accurate clinical recommendations for treating isolated diaphyseal femur fractures in children.

To develop the original guideline, the work group initially met in an introductory meeting on April 5, 2008, to establish the scope of the guideline and systematic review. Upon completion of the systematic review the work group participated in a two-day recommendation meeting on November 8 and 9, 2008, at which the final recommendations were written and voted on. The resulting draft guidelines were then peer-reviewed, subsequently sent for public commentary, and then sequentially approved by the AAOS Evidence Based Practice Committee, AAOS Guidelines and Technology Oversight Committee, AAOS Council on Research, Quality Assessment, and Technology, and the AAOS Board of Directors.

GUIDELINE REISSUE The original guideline and systematic review were prepared by the AAOS Pediatric Diaphyseal Femur Fractures physician work group with the assistance of the AAOS Clinical Practice Guidelines Unit. Based on the current procedure for updating AAOS guidelines, the Medical Librarian ran an updated search to identify literature published after the original search for the 2007 guideline that could address and possibly change the original recommendations. The AAOS Evidence-Based Medicine Unit then used the inclusion criteria from the original guideline to determine if any articles published after the final literature search date of the original guideline were relevant to the recommendations. The resulting reissue draft was then sequentially approved by the AAOS Committee on Evidence Based Quality and Value, the AAOS Council on Research and Quality and the AAOS Board of Directors (see Appendix I).

PRELIMINARY RECOMMENDATIONS The original work group began work on this guideline by constructing a set of preliminary recommendations. These recommendations specify [what] should be done in [whom], [when], [where], and [how often or how long]. They function as questions for the systematic review, not as final recommendations or conclusions. Simulated recommendations are almost always modified on the basis of the results of the systematic review. These recommendations also form the guideline’s scope and guide the searches for literature. These a priori simulated recommendations are inviolate in that, once specified, they cannot be modified, they must all be addressed by the systematic review, and the relevant review results must be presented in the final guideline. The a priori and inviolate nature of the preliminary recommendations combats bias.

STUDY SELECTION CRITERIA TYPES OF STUDIES We developed a priori article selection criteria for our review. Specifically, to be included in our systematic reviews an article had to be a report of a study that:

 Evaluated a treatment for isolated pediatric diaphyseal femur fracture.  Was a full article published in the peer reviewed literature.  Was an English language article published after 1965.  Was not a cadaveric, animal, or in vitro study.  Was not a retrospective case series, medical records review, meeting abstract, unpublished study report, case report, historical article, editorial, letter, or commentary.  Was the most recent report of a study or the report with the largest number of enrolled patients in a study with multiple publications.  Enrolled ≥ 10 patients in each of its study groups.  Enrolled a patient population of at least 80% of patients with a diaphyseal femur fracture and were not skeletally mature (closure of proximal and distal femoral growth plates).  Reported quantified results.  Enrolled patients without the following conditions  subtrochanteric fractures, supracondylar femur fractures, physeal fractures, open fractures, compound fractures, pathologic fractures, or multiple lower extremity fractures.  co-existing abdominal or neurological injuries requiring surgical intervention (the physician work group chair and co-chair determined whether an article met inclusion criteria in cases when studies reported insufficient detail to determine whether co-existing injuries required surgical intervention).  osteogenesis imperfecta, cerebral palsy, myelodysplasia (spina bifida), metabolic bone diseases, or skeletal dysplasia.

When examining primary studies, we analyzed the best available evidence regardless of study design. We first considered the randomized controlled trials identified by the search strategy. In the absence of two or more RCTs, we sequentially searched for prospective controlled trials, prospective comparative studies, retrospective comparative studies, and prospective case-series studies. Only studies of the highest level of available evidence were included, assuming that there were 2 or more studies of that higher level. For example, if there were two high quality studies that addressed the recommendation, moderate, low, and very low quality studies were not included.

For the recommendation on waterproof cast liners only, we considered for inclusion studies that included patients with conditions other than diaphyseal femur fractures

because the complications potentially avoided by using waterproof liners are not specific to diaphyseal femur fractures.

The Pediatric Diaphyseal Femur Fracture physician work group requested that the AAOS guidelines unit capture surrogate outcome measures if the study inclusion criteria were met. For this patient population, children, surrogate outcomes are often used because patients’ communication skills are limited or not yet developed. Surrogate outcome measures are laboratory measurements or another physical sign that are used as substitutes for clinically meaningful end points that measure directly how a patient feels, functions, or survives.10 In order for a surrogate measure to be valid, it must be in the causal pathway between the intervention and the outcome and it must demonstrate a large, consistently measurable association with the outcome.10

The main surrogate measures we considered were radiographic measures, such as those indicating a malunion of the fracture. It should be noted that generally accepted definitions of malunion have not necessarily been correlated to function and risk of developing further problems.

We only considered an outcome if ≥ 50% (80% for case series) of the patients were followed for that outcome (for example, some studies reported short-term outcomes data on nearly all enrolled patients, and reported longer-term data on only a few patients. In such cases, we did not include the longer-term data). We also excluded outcomes for study groups that did not have at least 10 patients.

When distinguishing between stable and unstable fractures, we defined transverse and short oblique fractures as stable. We defined comminuted and long oblique fractures as unstable.

When the age range of patients in a study overlapped the target age range of two or more recommendations, we included the study in the evidence base of the recommendation whose age range included the study’s median patient age.

ORIGINAL AND UPDATED LITERATURE SEARCHES The updated guideline searched for articles published up to November 27, 2013. The original guideline searched for articles published up to October 1, 2008. Search strategies were reviewed by the original work group prior to conducting the searches. All literature searches were supplemented with manual screening of bibliographies of all publications retrieved. We also searched the bibliographies of recent systematic reviews and other review articles for potentially relevant citations. A list of potentially relevant studies, not identified by the literature search, was also provided by the work group members. Three such studies met the inclusion criteria. We conducted one recommendation-specific search for primary articles on waterproof cast liners. For the entire guideline, thirty-two primary studies were included and two hundred forty-three studies were excluded.

SEARCH FOR RCTS AND OTHER STUDY DESIGNS To identify primary studies for this guideline, we searched four electronic databases; PubMed, EMBASE, CINAHL, and The Cochrane Central Register of Controlled Trials. The search strategies we used are provided in Appendix II.

We used a previously published search strategy 11 to identify relevant randomized controlled trials. In the absence of relevant RCTs, we modified the search strategy to identify studies of other designs.

The study attrition diagram in Appendix I provides details about the inclusion and exclusion of these studies.

DATA EXTRACTION Data elements extracted from studies were defined in consultation with the physician work group. Three reviewers completed data extraction independently for all studies. Disagreements were resolved by consensus and by consulting the work group. Evidence tables were constructed to summarize the best evidence pertaining to each preliminary recommendation. The elements extracted are shown in Appendix IV.

GRADING THE RECOMMENDATIONS Following data extraction and analyses, each guideline recommendation was assigned a preliminary grade that was based on the total body of evidence available using the following system:

Table 1. Grade of Recommendation Description Overall Strength of Strength Evidence Description of Evidence Strength Strength Visual Evidence from two or more “High” strength studies with consistent findings Strong Strong for recommending for or against the intervention. Evidence from two or more “Moderate” strength studies with consistent findings, Moderate Moderate or evidence from a single “High” quality study for recommending for or against the intervention. Evidence from two or more “Low” strength studies with consistent findings Low Strength or evidence from a single study for Evidence or recommending for or against the Limited Conflicting intervention or diagnostic test or the Evidence evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention. There is no supporting evidence. In the absence of reliable evidence, the work group is making a recommendation based on their clinical opinion. Consensus* No Evidence Consensus recommendations can only be created when not establishing a recommendation could have catastrophic consequences.

Each recommendation was constructed using the following language which took into account the final grade of recommendation.

Table 2 AAOS Guideline Language Strength of Guideline Language Recommendation Strong evidence supports that the practitioner Strong should/should not do X, because… Moderate evidence supports that the Moderate practitioner could/could not do X, because… Limited evidence supports that the practitioner Limited might/might not do X, because… In the absence of reliable evidence, it is the Consensus* opinion of this work group that…*

STATISTICAL METHODS We calculated, where applicable, odds ratios (OR) for dichotomous data and mean differences for continuous data.

When published studies only reported the median, range and size of the trial, we estimated their means and variances according to a published method.13

We used StatXact for the calculation of exact odds ratios confidence intervals for dichotomous data. All other calculations were performed using STATA 10.0 (StataCorp LP, College Station, Texas). We used the Wilson score method to calculate confidence intervals for proportions.14 For ordinal data, we used ordinal logistic regression to calculate odds ratios. Ordinal logistic regression produces proportional odds ratios, which assumes that the odds ratio is the same between each pair of outcome groups (lowest category vs. all higher categories, lowest two categories vs. all higher categories, etc.).

PEER REVIEW The original draft of the guideline and evidence report were peer reviewed by an expert outside advisory panel that was nominated by the physician work group prior to the development of the guideline (Appendix VI). In addition, the physician members of the AAOS Guidelines and Technology Oversight Committee and the Evidence Based Practice Committee provided peer review of the draft document. Peer review was accomplished using a structured peer review form. (Appendix VII) We forwarded the draft guideline to a total of thirty-three reviewers and eleven returned reviews. The disposition of all non-editorial peer review comments was documented and accompanied this guideline through the public commentary and the following approval process.

PUBLIC COMMENTARY After modifying the draft in response to peer review, the original guideline was subjected to a thirty day period of “Public Commentary.” Commentators consist of members of the AAOS Board of Directors (BOD), members of the Council on Research, Quality Assessment, and Technology (CORQAT), members of the Board of Councilors (BOC),

and members of the Board of Specialty Societies (BOS). Based on these bodies, up to 185 commentators had the opportunity to provide input into the development of this guideline. Of these, 12 returned public comments.

THE AAOS GUIDELINE APPROVAL PROCESS Following peer review, the 2009 CPG was approved by the AAOS Guidelines and Technology Oversight Committee, the AAOS Evidence Based Practice Committee, the AAOS Council on Research, Quality Assessment and Technology, and the AAOS Board of Directors.

The 2015 Guideline Reissue was approved by the AAOS Committee on Evidence Based Quality and Value, the AAOS Council on Research and Quality and the AAOS Board of Directors. Descriptions of these bodies are provided in Appendix I.

REVISION PLANS This guideline represents a cross-sectional view of current treatment and will become outdated when more sophisticated tests, more objective assessments, and more rigorous differential diagnoses are possible. Linkage to other disorders, genetic diagnosis, and occupational and human factors literature will contribute to our understanding of pediatric diaphyseal femur fractures.

Because of the pediatric population, changing medical reimbursement practices by all payors, and the high level of interest in this topic, the guideline will be revised in accordance with changing practice, rapidly emerging treatment options, new technology, and new evidence. This guideline will be revised or withdrawn in five years in accordance with the standards set forth by the National Guidelines Clearinghouse.

GUIDELINE DISSEMINATION PLANS Dissemination of the guideline is coordinated by the vice-chair of physician work group and the AAOS Evidence Based Quality and Value Coordinator. Dissemination efforts vary by guideline. Publication of most guidelines is announced by an Academy press release and corresponding articles authored by the vice chair and published in the Journal of the American Academy of Orthopaedic Surgeons and AAOS Now.

For selected guidelines, dissemination also includes developing a webinar, developing an Online Module for the Orthopaedic Knowledge Online website, producing a Radio Media Tour and producing Media Briefings. The guideline is also distributed at the AAOS Annual Meeting in various venues such as Academy Row and Committee Scientific Exhibits. It will also be distributed at applicable Continuing Medical Education (CME) courses and the AAOS Resource Center.

Other dissemination efforts outside the Academy will include submission of the guideline to the National Guideline Clearinghouse and distribution at other medical specialty societies’ meetings.

IV. RECOMMENDATIONS AND SUPPORTING DATA CHILD ABUSE Strong evidence supports that children younger than thirty-six months with a diaphyseal femur fracture be evaluated for child abuse.

Grade of Recommendation: Strong

Figures relevant to this recommendation are: Figure 1 Tables relevant to this recommendation are: Table 3

RATIONALE Our systematic review identified three high quality population-based studies that identified femur fractures in children caused by child abuse from three different registries. Two of these studies1,2 reported 14% and 12% of the fractures were the result of abuse in children zero to one year old and zero to three years old, respectively. The third study reported that only two (2%) of the fractures were caused by abuse among children zero to 15 years old, which would correspond to 13% if both of these fractures occurred in children zero to one year old.

The work group recognizes that the most important elements in evaluating a child for abuse are a complete history and physical exam with attention to the signs and symptoms of child abuse. The work group defines “evaluating” a child for abuse however, as not only these routine elements, but also including direct communication with the patient’s pediatrician or family doctor, consultation with the child abuse team at institutions where this may be available, and selective ordering of a skeletal survey by the orthopaedist when considered appropriate by the treating physician. In cases of possible child abuse, these professionals can add valuable input, based on experience, which increases the probability of identifying patients who may be at increased risk.15

In addition, the work group emphasizes that children who are not yet walking and sustain a femur fracture are at particular risk for abuse7, so one must make every attempt to identify these patients. One of the studies2 reports 48 of 49 child abuse-related femur fractures occurred in the less than three year old age group. This author found that in 332 femur fractures in children 0-3 years of age forty-eight of them were due to abuse. Accordingly, there were 451 children, four to twelve years of age, who had femur fractures and only one child in this age group was confirmed as abused. There were no cases of child abuse identified in the thirteen to seventeen year old age group. The work group acknowledges that this study is not exclusively reporting data on shaft fractures and has isolated the data specific to shaft fracture in the following data tables. However, the study does illustrate the need to focus on the patients who are less than three years old.

Estimates of child abuse suggest that the incidence is underreported and the consequences of missing it result in serious complications including death.2

SUPPORTING EVIDENCE Three population-based studies reported data addressing this recommendation. Hinton et al.1 used the Hospital Discharge Database of the Maryland Health Services Cost Review Commission from 1990-1996, Rewers et al.2 used the Colorado Trauma Registry from 1998-2001, and Miettinen et al.16 used a medical information register for University Central Hospital in Kuopio, Finland from 1976-1985.

Table 3. Incidence of Diaphyseal Femur Fractures Caused by Child Abuse % of Fractures Fractures Age Study Fractures Caused by Caused Group Child Abuse by Child Abuse Miettinen 0-15 yrs. 114 2 2% Rewers 0-3 yrs. 243 28 12% Not Reported Miettinen 0-1 yr. 15 specific to this Up to 13% age group* Hinton 0-1 yr. 73 10 14% * The authors of this study, Miettinen H., Makela E. A., and Vainio J. (1991), actually reported 2 cases of child abuse in 114 patients, one boy and one girl, 0-15 years of age. While they reported the incidence by age and gender, the authors did not report the distribution by cause of injury. For this calculation, the assumption was therefore made that both cases of child abuse that were reported, occurred in the 0-1 year old age group.

Figure 1. Incidence of Diaphyseal Femur Fractures Caused by Child Abuse

100% 90% 80% 70% 60% 50% 40% 13% 30% 14% 20% 12% 10% 2% 0% Hinton 1999 Rewers 2005 Miettinen 1991 Miettinen 1991 age 0-1 age 0-3 age 0-1 age 0-15

*AAOS computed the 95% Confidence Intervals from published data

Grade of Recommendation: Limited

Figures relevant to this recommendation are: Figure 2

RATIONALE The first 6 months of a child’s life is a time of most rapid growth. Because of this, rapid healing of diaphyseal femur fractures and post-fracture skeletal remodeling is maximal. Hence spontaneous, complete correction after fracture healing is expected. Due to the rapid union and complete remodeling, treatment of diaphyseal femur fractures centers on assuring ease of patient care and minimizing treatment complications. Both Pavlik harnesses and spica casts result in good outcomes with minimal complications. In the studies we reviewed, the only identifiable difference between these two treatments was more frequent skin complications in the spica cast group. Because this is a minor and correctable issue that does not cause long-term problems or disability, either type of treatment is an option.

SUPPORTING EVIDENCE Two studies addressed this recommendation. One retrospective comparative study17 compared the Pavlik harness to a spica cast, and one case series examined Pavlik harnesses.18 The case series reported that all 16 patients achieved stable union by 5 weeks in a Pavlik harness. In the comparative study, the spica cast group had significantly more skin complications (p<.01) than the Pavlik harness group, but there were no other statistically significant differences between groups. The Pavlik harness group was significantly younger (p=.028), with an average age of 3.6 months versus an average age of 6.5 months in the spica cast group.

Figure 2. Pavlik Harness vs. Spica Cast Odds

Outcome Duration Ratio (95% CI)

Loss of reduction 4 weeks 0.00 (0.00, 1.53)

Cast revision due to reduction loss 4 weeks 0.00 (0.00, 26.00)

Shortening during treatment 4 weeks 0.56 (0.11, 2.74)

Skin breakdown 4 weeks 0.00 (0.00, 1.53)

Superficial reactive dermatitis 4 weeks 0.00 (0.00, 1.53)

Total skin complications 4 weeks 0.00 (0.00, 0.45)

1 Pavlik Harness Spica Cast

Note on figures: Appendix contains information on how to interpret forest plots such as the one above as well as explanations of symbols used in this guideline’s figures and tables.

Grade of Recommendation: Moderate

Figures relevant to this recommendation are: Figure 3 - Figure 7 Tables relevant to this recommendation are: Table 4

RATIONALE Two studies compared the use of early spica casting with traction followed by spica casting. There were significantly more infections in the traction group and more spica softening and plaster breakage in the early spica group.19 There were no statistically significant differences between the treatment groups in time to union, femoral shortening, malalignment, or malrotation.19,20

Based on the summary of evidence, we did not find conclusive evidence that one modality of treatment (spica casting or traction) was superior and no studies compared flexible nails to spica casting in this age group. We suggest using early spica casting for social and economic considerations, specifically in relative ease of care and decreased length of hospital stay.21 While the work group suggests early spica for children in this age group, traction may be appropriate in some cases. This recommendation does not suggest against the use of traction. In keeping with current best medical practice, we further suggest careful clinical and radiographic follow-up during the course of treatment.

In addition, no trial has specifically examined children in the age group of 4-5 years. A third study22 indicates that in children as young as four more malunions occur with spica casting than with external fixation. Treatment decisions made on children who border any age group should be made on the basis of the individual. Until further research clarifies the possible harms associated with any treatment in this age group, decisions will always need to be predicated on guardian and physician mutual communication with discussion of available treatments and procedures applicable to the individual patient. Once the patient’s guardian has been informed of available therapies and has discussed these options with his/her child’s physician, an informed decision can be made. Clinician input based on experience increases the probability of identifying patients who will benefit from specific treatment options.

SUPPORTING EVIDENCE Two High Quality studies addressed this recommendation. One study20 included patients 2-10 years old, with 54% of the patients between ages 2-5. The other study19 included patients 9 months – 10 years old, with a mean age in both groups of 3.5 years.

One High quality study,22 with a mean patient age of 6 years old, but that addressed harms in children as young as 4 was also included to address this recommendation. (See Recommendation 8)

Summary of Evidence

Table 4. Summary of Evidence Level of Author n Comparison Outcome (follow-up duration) Result Evidence Burton High 183 Time to Union (n/a) ○ Burton High 183 Shortening (at Union) ○ Rasool High 170 Shortening at (6 wk) ○ Burton High 183 Varus angulation (at Union) ○ Rasool High 170 Varus angulation (6 wk) ○ Burton High 183 Valgus angulation (at Union) ○ Rasool High 170 Valgus angulation (6 wk) ○ Burton High 183 Anterior Bowing (at Union) ○ Spica Cast vs. Rasool High 170 Anterior Bowing (6 wk) Traction ○ Burton High 183 Posterior Bowing (at Union) ○ Rasool High 170 Posterior Bowing (6 wk) ○ High Rasool 170 Infectious disease contraction (6 wk) ● sc Rasool High 170 Pressure from ring of splint (6 wk) ○ Rasool High 170 Blisters (6 wk) ○ High Rasool 170 Spica softening (6 wk) ● t High Rasool 170 Plaster breakage (6 wk) ● t Rasool High 170 Soilage (6 wk) ○ ● = result is statistically significant n/a = not applicable sc = spica cast ○ = result is not statistically significant nr = not reported t = traction

Figure 3. Time Immobilized (Time to Union)

Outcome Study OR (95% CI)

Time to Union Burton 0.86 (0.48, 1.56)

1 Spica Cast Traction

*Odds Ratio from ordered logistic regression (AAOS calculation)

Figure 4. Shortening

Study Duration OR (95% CI)

Burton Union 1.18 (0.69, 2.02)

Rasool 6 weeks 0.79 (0.45, 1.39)

1 Spica Cast Traction

*Odds Ratios from ordered logistic regression (AAOS calculation)

Figure 5. Angulation

Outcome Study Duration OR (95% CI)

Varus Angulation Burton Union 1.02 (0.56, 1.85)

Rasool 6 weeks 0.70 (0.38, 1.29)

Valgus Angulation Burton Union 0.94 (0.42, 2.15)

Rasool 6 weeks 0.82 (0.19, 3.39)

1 Spica Cast Traction

*Odds Ratios from ordered logistic regression (AAOS calculation)

Figure 6. Bowing

Outcome Study Duration OR (95% CI)

Anterior Bowing Burton Union 1.53 (0.87, 2.67)

Rasool 6 weeks 1.16 (0.64, 2.10)

Posterior Bowing Burton Union 0.74 (0.25, 2.15)

Rasool 6 weeks 0.00 (0.00, 1.49)

1 Spica Cast Traction

*Anterior Bowing Odds Ratios from ordered logistic regression (AAOS calculation)

Figure 7. Complications

Outcome Study Duration OR (95% CI)

Infectious disease contraction Rasool 6 weeks 0.12 (0.01, 0.57)

Blisters Rasool 6 weeks 0.00 (0.00, 1.49)

Pressure from ring of splint Rasool 6 weeks 0.00 (0.00, 2.40)

Spica softening Rasool 6 weeks 1000.00 (2.42, 1000.00)

Plaster breakage Rasool 6 weeks 1000.00 (1.22, 1000.00)

Soilage Rasool 6 weeks 1000.00 (0.67, 1000.00)

1 Spica Cast Traction

PREVIOUSLY PUBLISHED SYSTEMATIC REVIEWS Two previous systematic reviews21,23 concluded that early spica casting was associated with shorter inpatient hospital stays and fewer adverse events than traction. Both of these reviews, however, were not specific to the population of interest for this recommendation, so we did not include them in our systematic review.

Grade of Recommendation: Limited

Figures relevant to this recommendation are: Figure 8 - Figure 31 Tables relevant to this recommendation are: Table 6 - Table 11

RATIONALE There are few statistically significant differences between treatments in healing of the fracture. The evidence reviewed included ten studies that examined one hundred varying outcomes. Of these one hundred outcomes twenty-one were significant. There were no studies that directly compared flexible nails to spica casting. When flexible nails were compared to external fixation and traction plus casting, nine outcomes were significant favoring flexible nails, one significant outcome favored external fixation and one significant outcome favored traction plus casting. (Please refer to Tables 6 and 7 below.)

The high quality study22 found to address this recommendation compared external fixation to spica casting. External fixation was favored over spica casting for malunions, including anterior/posterior angulation. Twelve other outcomes for this comparison had non-significant results.

In summary, the overall body of evidence considered for this recommendation indicates that there are few significant outcomes when all comparisons are considered. Further, important comparisons have not been investigated (spica casting and flexible nails).

Two moderate quality studies24, 50 shows more rapid return to walking and school with flexible intramedullary nailing and one low quality study25 illustrates less associated hospital costs when compared to traction and casting. The ability to mobilize the patient, return them to school rapidly, and suggested decrease in hospital costs leads the work group to suggest flexible intramedullary nailing over traction followed by casting. There is evidence that flexible intramedullary nailing has less adverse events and more rapid return to school than external fixation in both stable and unstable fractures.26

In making this recommendation, the work group acknowledges that they are including their expert opinion and they have therefore, downgraded the Grade of this Recommendation to a “limited” recommendation. Based on the advantages suggested, less adverse events and more rapid return to school, flexible intramedullary nailing is a treatment option for children five to eleven years diagnosed with diaphyseal femur fractures.

There is currently insufficient literature in specially designed pediatric rigid intramedullary nails and bridge plating for inclusion in the current guideline.

Patients over age 11 or with weight over 49 kg are at increased risk of a poor outcome27 with flexible intramedullary nailing. The mean weight between patients with a poor outcome and those with an excellent or satisfactory outcome was significant, but weight was not independent of age and had a sensitivity of only 59% in predicting poor outcomes.

SUPPORTING EVIDENCE One High quality study,22 six moderate quality studies24,28-31, 50 and eight low quality studies25,26,32-37 addressed this recommendation. Low quality studies are included in this recommendation because they examine treatments not compared in the high and moderate quality studies. The average age of the patients enrolled in these studies was 4- 11 years but ten studies included patients outside of this range.

One very low quality study27 addressed the issue of patient weight as a criterion for the use of flexible nailing in this age group by comparing the weight of patients with an excellent or satisfactory outcome to the weight of patients with a poor outcome. Sixty percent (60%) of the patients in this study were less than 11 years old. The 15 kg difference in mean weight between patients with a poor outcome and those with an excellent or satisfactory outcome was statistically significant according to the author’s calculations (p=.003). Moreover, using a cut-off point of 49 kg, heavier patients were about five times more likely than lighter patients to have poor outcomes. However, the investigators found that weight did not independently predict a poor outcome when age was also included in a logistic regression model. The investigators also found that the weight cut-off point had 78.5% specificity and 59% sensitivity for detecting a poor outcome.

Table 5. Summary of Updated Findings for Titanium Elastic Nailing Study Quality N Comparison Outcome Author Result p-value Hopital Stay (days) <0.001 TEN Time to start <0.001 TEN walking with aids(days) Time to start <0.001 TEN walking independently TEN vs. Shemshaki,H.R., Moderate (days) 46 Traction + spica 2011 Time to return to <0.001 TEN casting school (days) Knee range of 0.078 NS motion (degrees) Malunion 0.117 NS Infection 0.117 NS Parent satisfaction- 0.003 TEN excellent

Table 6. Flexible Intramedullary Nailing and Patients’ Weight Mean weight Mean weight (poor Treatment n (excellent/satisfactory p-value outcome) outcome) Titanium 54 kg (range 22.3 to 222 39 kg (range 17 to 95.2) 0.003 Elastic Nailing 95.2)

Summary of Evidence: For summary of significant outcomes see Table 7 on page 23. For summary of nonsignificant outcomes see Table 8 on page 24. For summary of High quality evidence see Table 9 on page27. For summary of High Qualityevidence see Table 10 on page 28. For summary of High Quality evidence see Table 11 on page 30.

Table 7. Summary of Significant Outcomes with Level of Evidence TREATMENT FAVORED Traction (+ Flexible Nails External Fixation Spica Cast Casting) Flexible Loss of movement at Irritation at nail N/A Nails knee (post-op)/III entry site/II Duration of Time to full knee External Duration of treatment/I treatment/III movement/III N/A Fixation Pin-tract infections/I Duration of Return to school/III treatment/III Malunion/I Spica Cast Anterior/Posterior N/A Angulation/I Walking with aids/II Walking Blisters/superficial independently/II ulcers/II Walking Traction (+ Knee flexion independently/II Patient satisfaction/III N/A Casting) contraction/II Return to school/II Overall short-term Angular complications/II deformity/III Flynn’s outcome/III Acceptable scar/III *Number of outcomes examined: 100 **Number of significant outcomes: 21 ***Number of studies:10 ****Number of nonsignificant outcomes: Flexible nails: 49 External fixation: 26 Spica cast: 27 Traction and casting: 56

Table 8. Summary of Nonsignificant Outcomes with Level of Evidence

External Comparisons Spica Cast Traction + Casting Fixation Full Weight Severe knee Overgrowth 9- Minor bearing (n/a)/III stiffness (1 10 mm (8.5 complications Re/antecurvatum yr)/II mo)/III (nr)/ III malalignment 5 Unequal length Shortening 7-8 Remove/reinsert to 10 degrees or mm (8.5 traction pin (nr)/III unacceptable mo)/III (nr)/III Varus/valgus angulation (6 Age-defined Nonfemoral malalignment 5 mo)/II malunion (8.5 lower ext. stress to 10 degrees Shortening (6 mo)/III fx. (nr)/III (nr)/III mo)/II Coronal Infected pin site Limb length Malrotation (6 malunion (8.5 (nr)/III discrepancy up mo)/II mo)/III Pin track to 1 cm (final Delayed union Sagittal infection (2 review)/III (1 yr)/II malunion (8.5 yr)/III Pain (final Loss of mo)/III Skin irritation review)/III reduction (1 Leg length (2 yr)/III Loss of yr)/II discrepancy > Persistent movement at hip Pressure ulcer 1cm (2 yr)/III drainage from (post-op)/III (1 yr)/II Would choose pin site (nr)/III Foot drop Refracture (1 same treatment Proudflesh (nr)/III yr)/II (nr)/III (nr)/III Early removal of Second Mean leg Pin migration nail (nr)/III Surgery length (nr)/III Superficial (1yr)/II discrepancy (2 Pain syndrome Flexible infection (nr)/III Pin end yr)/III (nr)/III No studies Nails Deep Infection irritation (6 Major Cast (nr)/III mo)/II complications wedging/fx. Refracture Nail removal (8.5 mo)/III manipulate (8.5 (nr)/III due to Refracture (8.5 mo)/III irritation (1 mo)/III Revision of nail yr)/II Osteoclasis (8.5 mo)/III Infection (6 (8.5 mo)/III Broken nail (2 mo)/II Pulmonary yr)/III Overall embolism (8.5 complications mo)/III (1 yr)/II

Table 8. Summary of Nonsignificant Outcomes with Level of Evidence (continued)

External Comparisons Spica Cast Traction + Casting Fixation

Malunion inc. rotation (2 yr)/I Leg length discrepancy ≥ 2 cm (2 yr)/I Varus/valgus angulation ≥ 10° (2 yr)/I Rotational Malunion (2 yr)/I Treatment alteration (2 yr)/I Unacceptable loss Total treatment days until union/III External N/A of reduction (2 Reoperation (until union)/III Fixation yr)/I Patient Satisfaction/III RAND overall (2 yr)/I Duration of treatment (n/a)/I Behavioural Questionnaire (post-hosp)/I Parent Satisfaction (2 yr)/I Child Satisfaction (2 yr)/I Refracture (2 yr)/I

Table 8. Summary of Nonsignificant Outcomes with Level of Evidence (continued) External Comparisons Spica Cast Traction + Casting Fixation

Shortening (1 yr)/II Union time (n/a)/II Coronal angulation (1 yr) /II Sagittal angulation (1 yr)/II Excessive override (3 mo)/II Varus angulation > 10° (3 mo/II) Valgus angulation > 10° (3 mo)/II Spica Cast N/A N/A Posterior angulation > 10° (3 mo)/II Delayed union (3 mo)/II Readmission for manipulation (3 mo)/II Pin-tract infection (3 mo)/II Post-cast fracture of ipsi. limb (3 mo)/II Spinal muscular atrophy(3 mo)/II Fever of unknown origin (3 mo)/II Cast sore (3 mo)/II

*Number of outcomes examined: 100 **Number of significant outcomes: 21 (See Table 6) ***Number of studies:10 ****Number of nonsignificant outcomes: Flexible nails: 49 External fixation: 26 Spica cast: 27 Traction and casting: 56

Table 9. Summary of High Quality Evidence Level of Author n Comparison Outcome (follow-up duration) Result Evidence Wright High 101 Malunion (2 yr) ● ef Wright High 101 Malunion inc. rotation (2 yr) ○ Wright High 101 Leg length discrepancy ≥ 2 cm (2 yr) ○ Wright High 101 Ant/post. angulation ≥ 15° (2 yr) ● ef Wright High 101 Varus/valgus angulation ≥ 10° (2 yr) ○ Wright High 101 Rotational Malunion (2 yr) ○ Wright High 101 Treatment alteration (2 yr) ○ Wright High 101 External Fixation Unacceptable loss of reduction (2 yr) ○ Wright High 101 vs. Early Spica Cast RAND overall (2 yr) ○ Wright High 101 RAND physical subscale (2 yr) ○ Wright High 101 Duration of treatment (n/a) ● sc Wright High 101 Behavioural Questionnaire (post-hosp) ○ Wright High 101 Parent Satisfaction (2 yr) ○ Wright High 101 Child Satisfaction (2 yr) ○ Wright High 101 Refracture (2 yr) ○ Wright High 101 Pin-tract infections (2 yr) ● sc ● = result is statistically significant n/a = not applicable ef = external fixation ○ = result is not statistically significant nr = not reported sc = spica cast

Table 10. Summary of Moderate Quality Evidence Level of Author n Comparison Outcome (follow-up duration) Result Evidence Domb Moderate 49 Early Callus (n/a) ○ Domb Moderate 49 Complete Healing (n/a) ○ Dynamic vs. Static Domb Moderate 49 Removal of external fixator (n/a) External Fixation ○ Domb Moderate 49 Full weight bearing (n/a) ○ Domb Moderate 49 Angulation (nr) ○ Flynn Moderate 83 Severe knee stiffness (1 yr) ○ Unequal length Flynn Moderate 83 or unacceptable angulation (6 mo) ○ Mehdinasab Moderate 66 Shortening (6 mo) ○ Mehdinasab Moderate 66 Malrotation (6 mo) ○ Flynn Moderate 83 Delayed union (1 yr) ○ Flynn Moderate 83 Loss of reduction (1 yr) ○ Flynn Moderate 83 Walking with aids (n/a) ● fn Flynn Moderate 83 Walking independently (n/a) ● fn Mehdinasab Moderate 66 Traction and cast Walking independently (n/a) ● fn vs. Flexible Nails Flynn Moderate 83 Return to school ● fn Flynn Moderate 83 Pressure ulcer (1 yr) ○ Flynn Moderate 83 Refracture (1 yr) ○ Flynn Moderate 83 Second surgery (1 yr) ○ Flynn Moderate 83 Irritation at nail entry site (1 yr) ● t/c Mehdinasab Moderate 66 Pin end irritation (6 mo) ○ Flynn Moderate 83 Nail removal due to irritation (1 yr) ○ Mehdinasab Moderate 66 Infection (6 mo) ○ Flynn Moderate 83 Overall complications (1 yr) ○ ● = result is statistically significant n/a = not applicable fn = flexible nails ○ = result is not statistically significant nr = not reported t/c = traction and cast (continued next page)

Table 10. Summary of Moderate Quality Evidence (continued) Level of Author n Comparison Outcome (follow-up duration) Result Evidence Ali Moderate 66 Shortening (1 yr) ○ Ali Moderate 100 Union time (n/a) ○ Early spica cast vs. Ali Moderate 66 Coronal angulation (1 yr) traction ○ Ali Moderate 66 Sagittal angulation (1 yr) ○ Ali Moderate 100 Blisters/superficial ulcers (until union) ● sc Curtis Moderate 91 Excessive override (3 mo) ○ Curtis Moderate 91 Varus angulation > 10° (3 mo) ○ Curtis Moderate 91 Valgus angulation > 10° (3 mo) ○ Curtis Moderate 91 Posterior angulation > 10° (3 mo) ○ Curtis Moderate 91 Delayed union (3 mo) ○ Curtis Moderate 91 Knee flexion contraction > 20° (3 mo) psc Early pontoon spica ● Curtis Moderate 91 cast vs. traction, Readmission for manipulation (3 mo) ○ then spica cast Curtis Moderate 91 Pin-tract infection (3 mo) ○ Curtis Moderate 91 Post-cast fracture of ipsi. limb (3 mo) ○ Curtis Moderate 91 Spinal muscular atrophy(3 mo) ○ Curtis Moderate 91 Fever of unknown origin (3 mo) ○ Curtis Moderate 91 Cast sore (3 mo) ○ Curtis Moderate 91 Overall short-term complication (3 mo) ● psc ● = result is statistically significant n/a = not applicable sc = spica cast ○ = result is not statistically significant nr = not reported psc = (pontoon) spica cast

Table 11. Summary of Low Quality Evidence Level of Author n Comparison Outcome (follow-up duration) Result Evidence Nork Low 29 External fixation vs. Total treatment days (until union) ○ Nork Low 29 traction and cast Reoperation (until union) ○ Hedin 2004 Low 59 External fixation vs. Duration of treatment (n/a) ● t Hedin 2004 Low 66 home traction Patient satisfaction (nr) ○ Hedin 2004 Low 59 External fixation vs. Duration of treatment (n/a) ● t hospital traction Hedin 2004 Low 66 Patient satisfaction (nr) ● ef Buechsensc. Low 71 Overgrowth 9-10 mm (8.5 mo) ○ Buechsensc. Low 71 Shortening 7-8 mm (8.5 mo) ○ Buechsensc. Low 71 Age-defined malunion (8.5 mo) ○ Buechsensc. Low 71 Coronal malunion (8.5 mo) ○ Buechsensc. Low 71 Sagittal malunion (8.5 mo) ○ Song Low 51 Angular deformity (2 yr) ● fn Song Low 51 Leg length discrepancy > 1cm (2 yr) ○ Song Low 51 Flynn’s outcome (2 yr) ● fn Buechsensc. Low 43 Flexible nails vs. Would choose same treatment (nr) ○ traction and cast Buechsensc. Low 43 Acceptable scar (nr) ● fn Song Low 51 Mean leg length discrepancy (2 yr) ○ Buechsensc. Low 71 Major complications (8.5 mo) ○ Buechsensc. Low 71 Refracture (8.5 mo) ○ Buechsensc. Low 71 Osteoclasis (8.5 mo) ○ Buechsensc. Low 71 Cast wedging/fx. manipulate (8.5 mo) ○ Buechsensc. Low 71 Revision of nail (8.5 mo) ○ Song Low 51 Broken nail (2 yr) ○ Buechsensc. Low 68 Pulmonary embolism (8.5 mo) ○ ● = result is statistically significant n/a = not applicable t = traction ef = external fixation ○ = result is not statistically significant nr = not reported fn = flexible nails (continued next page)

Table 11. Summary of Low Quality Evidence (continued) Level of Author n Comparison Outcome (follow-up duration) Result Evidence Buechsensc. Low 71 Minor complications (nr) ○ Buechsensc. Low 71 Remove/reinsert traction pin (nr) ○ Buechsensc. Low 71 Nonfemoral lower ext. stress fx. (nr) ○ Buechsensc. Low 71 Infected pin site (nr) ○ Song Low 51 Flexible nails vs. Pin track infection (2 yr) ○ Song Low 51 traction and cast Skin irritation (2 yr) ○ Buechsensc. Low 71 Persistent drainage from pin site (nr) ○ Buechsensc. Low 71 Proudflesh (nr) ○ Buechsensc. Low 71 Pin migration (nr) ○ Buechsensc. Low 71 Pain syndrome (nr) ○ Wall Low 104 Malunion (1 yr) ● ss Wall Low 104 Osteotomy (1 yr) ○ Wall Low 104 Infection (1 yr) ○ Wall Low 104 Titanium vs. Implant revision (1 yr) ○ stainless steel Wall Low 104 flexible nail Nail irritation (1 yr) ○ Wall Low 104 Nail breakage (1 yr) ○ Wall Low 104 Delayed union (3 mo) ○ Wall Low 104 Minor complications (1 yr) ○ Rasit Low 40 Immediate vs. 2nd surgery/loss of reduction(2 wk) ○ delayed spica cast Rasit Low 40 Angulation > 20° (2 wk) ○ Sturdee Low 56 Pain (3 mo) ○ Sturdee Low 56 Malunion (3 mo) ○ Sturdee Low 56 Pin-site infections (until union) ○ Early intervention Broken external fixation pin Sturdee Low 56 vs. traction (until union) ○ Sturdee Low 56 Refracture (until union) ○ Reapplication of traction pin Sturdee Low 56 (until union) ○ Sturdee Low 56 Pressure sores (until union) ○ ● = result is statistically significant n/a = not applicable ss = stainless steel ○ = result is not statistically significant nr = not reported (continued next page)

Table 11. Summary of Low Quality Evidence (continued) Level of Author n Comparison Outcome (follow-up duration) Result Evidence Barlas Low 40 Full weight bearing (n/a) ○ Barlas Low 40 Time to full knee movement (n/a) ● fn Barlas Low 40 Return to school (n/a) ● fn Re/antecurvatum Barlas Low 40 malalignment 5° to 10° (nr) ○ Varus/valgus Barlas Low 40 malalignment 5° to 10° (nr) ○ Limb length discrepancy, Barlas Low 40 up to 1 cm (final review) ○ Flexible nailing Barlas Low 40 vs. external Pain (final review) ○ fixation Barlas Low 40 Loss of movement at hip (post-op) ○ Barlas Low 40 Loss of movement at knee (post-op) ● ef Barlas Low 40 Foot drop (nr) ○ Barlas Low 40 Early removal of nail (nr) ○ Barlas Low 40 Superficial infection (nr) ○ Barlas Low 40 Deep infection (nr) ○ Barlas Low 40 Refracture (nr) ○ ● = result is statistically significant n/a = not applicable fn = flexible nailing ○ = result is not statistically significant nr = not reported ef = external fixation

Figure 8. External Fixation vs. Spica Cast - binary outcomes (Wright et al.22) Odds Outcome Ratio (95% CI)

Malunion 0.23 (0.07, 0.64) Malunion inc. rotation 0.50 (0.21, 1.19) Leg length discrepancy >=2cm 0.50 (0.08, 2.38) Anterior/posterior angulation >= 15 deg 0.24 (0.07, 0.77) Varus/valgus angulation >=10 deg 0.40 (0.01, 5.25) Rotational malunion 0.71 (0.27, 1.82) Treatment alteration 1.11 (0.31, 3.84) Unacceptable loss of reduction 0.00 (0.00, 1.01)

1 External Fixation Spica Cast

Figure 9. External Fixation vs. Spica Cast -continuous outcomes (Wright et al.22)

Mean

Outcome Difference (95% CI)

RAND overall 1.00 (-4.20, 2.10)

RAND physical subscale 0.10 (-0.30, 0.60)

Duration of treatment (weeks) 2.71 (1.57, 4.00)

Post-hospitalizaiton behavioural questionnaire -0.50 (-5.90, 4.90)

Parent satisfaction -0.10 (-0.60, 0.30)

Child satisfaction 0.80 (-0.50, 2.20)

0 External Fixation Spica Cast

Figure 10. External Fixation vs. Spica Cast - Complications (Wright et al.22)

Outcome Odds Ratio (95% CI)

Refracture 1000.00 (0.23, 1000.00)

Pin-tract infections 1000.00 (9.80, 1000.00)

1 External Fixation Spica Cast

Figure 11. Dynamic vs. Static External Fixation (Domb et al.28)

Mean

Outcome Difference (95% CI)

Early Callus (days) -1.70 (-8.36, 4.96)

Complete Healing (days) 7.00 (-7.12, 21.12)

Removal of external fixator (days) 12.60 (-4.79, 29.99)

Full Weight-Bearing (days) 7.80 (-7.40, 23.00)

Angulation (°) -1.30 (-2.70, 0.10)

0 Dynamic Static

Figure 12. Traction & Cast vs. Flexible Nails –binary outcomes

Outcome Study Odds Ratio (95% CI)

Severe knee stiffness Flynn 1000.00 (0.04, 1000.00)

Unequal length or Flynn 1000.00 (0.58, 1000.00) unacceptable angulation Shortening Mehdinasab 5.38 (0.48, 273.00)

Malrotation Mehdinasab 1000.00 (0.51, 1000.00)

Delayed union Flynn 0.00 (0.00, 53.50)

Loss of reduction Flynn 1000.00 (0.26, 1000.00)

1 Traction/Cast Flexible Nails

Figure 13. Traction & Cast vs. Flexible Nails – continuous outcomes

Mean Difference Outcome Study (days) (95% CI)

Walking with aids Flynn 56.00 (29.00, 83.00)

Walking independently Flynn 39.00 (20.00, 58.00)

Total treatment course Mehdinasab 14.10 (13.10, 15.10) (until independent walking) Return to school Flynn 55.00 (28.00, 82.00)

0 Traction/Cast Flexible Nails

Figure 14. Traction & Cast vs. Flexible Nails - Complications

Outcome Study Odds Ratio (95% CI)

Pressure ulcer Flynn 1000.00 (0.95, 1000.00)

Refracture Flynn 2.85 (0.14, 172.00)

Second surgery Flynn 2.16 (0.23, 26.90)

Irritation at nail entry site Flynn 0.00 (0.00, 0.73)

Pin end irritation Mehdinasab 0.00 (0.00, 1.76)

Nail removal due to irritation Flynn 0.00 (0.00, 7.30)

Infection Mehdinasab 0.00 (0.00, 47.00)

Overall complication Flynn 1.98 (0.66, 5.99)

1 Traction/Cast Flexible Nails

Figure 15. Early Spica Cast vs. Traction - continuous outcomes (Ali et al.30)

Mean

Outcome Difference (95% CI)

Shortening (cm) -0.06 (-0.25, 0.13)

Union time (weeks) 0.04 (-0.63, 0.71)

Angulation in coronal plane (°) 0.06 (-2.04, 2.16)

Angulation in sagittal plane (°) -0.46 (-2.77, 1.85)

0 Spica Cast Traction

Figure 16. Early Spica Cast vs. Traction -Complications (Ali et al.30)

Odds

Outcome Ratio (95% CI)

Blisters/superficial ulcers 0.00 (0.00, 0.64)

1 Spica Cast Traction

Figure 17. Early Pontoon Spica vs. Traction/Cast – Short-term Complications (Curtis et al.31)

Outcome Odds Ratio (95% CI)

Excessive override 0.00 (0.00, 11.70) Varus Angulation > 10° 0.29 (0.00, 23.90) Valgus Angulation > 10° 1000.00 (0.01, 1000.00) Posterior Angulation > 10° 0.29 (0.00, 23.90) Delayed union 0.59 (0.03, 36.40) Knee Flexion Contraction >20° 0.02 (0.00, 0.17) Readmission for remanipulation 1000.00 (0.12, 1000.00) Pin-tract infection 1000.00 (0.01, 1000.00) Post-cast fracture of ipsilateral limb 0.00 (0.00, 1.56) Spinal Muscular Atrophy 0.00 (0.00, 11.70) Fever of Unknown Origin 0.00 (0.00, 11.70) Cast sore 1000.00 (0.01, 1000.00) Overall Short-term Complications 0.21 (0.06, 0.69)

1 Pontoon Spica Traction/Cast

Figure 18. External Fixation vs. Traction & Cast - Treatment Length (Nork et al.32)

Mean Outcome Difference (95% CI)

Total treatment 10.10 (-2.40, 22.60) days (fracture union)

0 External Fixation Traction/Cast

Figure 19. External Fixation vs. Traction & Cast – Complications (Nork et al.32)

Outcome Duration Odds Ratio (95% CI)

Reoperation Until Union 1.71 (0.08, 109.40)

1 External Fixation Traction/Cast

Figure 20. External Fixation vs. Traction - Treatment Length (Hedin et al.34)

Mean

Outcome Type of Traction Difference (95% CI)

Duration of treatment (days) Home Traction 12.00 (9.40, 14.60)

Duration of treatment (days) Hospital Traction 17.00 (14.80, 19.20)

0 External Fixation Traction

Figure 21. External Fixation vs. Traction - Patient Satisfaction (Hedin et al.34)

Outcome Type of Traction Odds Ratio (95% CI)

Patients' satisfaction Home Traction 4.44 (0.63, 33.70)

Patients' satisfaction Hospital Traction 14.50 (3.03, 89.70)

1 External Fixation Traction

Figure 22. Flexible Nails vs. Traction & Cast - binary outcomes

Outcome Study Duration Odds Ratio (95% CI)

Overgrowth 9-10 mm Buechsenschuetz 8.5 months 0.70 (0.06, 5.35)

Shortening 7-8mm Buechsenschuetz 8.5 months 3.04 (0.00, 183.50)

Age-defined Malunion Buechsenschuetz 8.5 months 1.40 (0.40, 4.81)

Coronal malunion Buechsenschuetz 8.5 months 1.04 (0.23, 4.34)

Sagittal malunion Buechsenschuetz 8.5 months 4.73 (0.00, 254.00)

Angular Deformity Song 2 years 4.20 (1.20, 14.70)

Leg Length Discrepancy > 1cm Song 2 years 1000.00 (0.79, 1000.00)

Flynn's Outcome Song 2 years 4.09 (1.31, 12.80)

Would choose same treatment againBuechsenschuetz Not Reported 390.00 (0.00, 16949.99)

Acceptable scar Buechsenschuetz Not Reported 7.50 (1.10, 83.60)

1 Traction/Cast Flexible Nails

Figure 23. Flexible Nails vs. Traction & Cast -Leg Length Discrepancy (Song et al.33)

Mean Outcome Duration Difference (95% CI)

Mean Leg Length 2 1.70 (-0.45, 3.85) Discrepancy (mm) years

0 Traction/Cast Flexible Nails

Figure 24. Flexible Nails vs. Traction & Cast - Major Complications

Outcome Study Odds Ratio (95% CI)

Major complications Buechsenschuetz 2.31 (0.24, 29.00)

Refracture Buechsenschuetz 1000.00 (0.04, 1000.00)

Osteoclasis Buechsenschuetz 1000.00 (0.04, 1000.00)

Cast wedging/fracture manipulation Buechsenschuetz 1000.00 (0.04, 1000.00)

Revison of nail Buechsenschuetz 0.00 (0.00, 56.50)

Broken nail Song 0.00 (0.00, 44.00)

Pulmonary Emoblism Buechsenschuetz 0.00 (0.00, 63.00)

1 Traction/Cast Flexible Nails

Figure 25. Flexible Nails vs. Traction & Cast - Minor Complications

Outcome Study Odds Ratio (95% CI)

Minor Complications Buechsenschuetz 2.63 (0.75, 9.48)

Removal & reinsertion of traction pin Buechsenschuetz 1000.00 (0.62, 1000.00)

Nonfemoral lower extremity stress fx Buechsenschuetz 1000.00 (0.62, 1000.00)

Infected pin site Buechsenschuetz 1000.00 (0.27, 1000.00)

Pin track infection Song 1000.00 (0.21, 1000.00)

Skin irritation Song 0.00 (0.00, 2.67)

Persistent drainage from pin site Buechsenschuetz 1000.00 (0.04, 1000.00)

Proudflesh Buechsenschuetz 1000.00 (0.04, 1000.00)

Pin migration Buechsenschuetz 0.00 (0.00, 1.61)

Pain syndrome Buechsenschuetz 0.00 (0.00, 56.50)

1 Traction/Cast Flexible Nails

Figure 26. Titanium vs. Stainless Steel Flexible Nails – Complications (Wall et al.37)

Outcome Duration Odds Ratio (95% CI)

Malunion 1 year 4.53 (1.12, 26.20)

Osteotomy 1 year 1000.00 (0.00, 1000.00)

Infection 1 year 1000.00 (0.36, 1000.00)

Implant Revision 1 year 0.85 (0.11, 6.67)

Nail Irritation 1 year 0.85 (0.11, 6.67)

Nail Breakage 1 year 0.85 (0.01, 68.50)

Delayed union 3 months 0.00 (0.00, 33.00)

Minor Complications 1 year 1.77 (0.24, 20.30)

1 Titanium Stainless Steel

Figure 27. Immediate vs. Delayed Spica Cast - Complications (Rasit et al.35)

Outcome Duration Odds Ratio (95% CI)

Second surgery due to loss of reduction 2 weeks 1000.00 (0.12, 1000.00)

Loss of reduction 2 weeks 1000.00 (0.12, 1000.00)

Angulation of > 20° 2 years 0.00 (0.00, 1.23)

1 Immediate Spica Delayed Spica

Figure 28. Early Intervention vs. Traction (Sturdee et al.36)

Outcome Duration Odds Ratio (95% CI)

Pain 3 months 1000.00 (0.03, 1000.00)

Malunion 3 months 1.10 (0.30, 3.93)

Pin-site Infections Until Union 2.70 (0.13, 164.10)

Broken external fixation pin Until Union 1000.00 (0.03, 1000.00)

Refracture Until Union 1000.00 (0.03, 1000.00)

Reapplication of traction pin Until Union 0.00 (0.00, 52.00)

Pressure Sores Until Union 0.00 (0.00, 7.10)

1 Early Intervention Traction

Figure 29. Flexible Nailing vs. External Fixation - Continuous Outcomes (Barlas et al. 200626)

Mean

Outcome Difference (95% CI)

Full Weight-bearing (weeks) -1.00 (-2.01, 0.01)

Time to full knee movement (weeks) -7.00 (-8.22, -5.78)

Return to school (weeks) -7.00 (-7.96, -6.04)

0 Flexible Nailing External Fixation *Standard deviations estimated from range

Figure 30. Flexible Nailing vs. External Fixation -Binary Outcomes (Barlas et al. 200626)

Outcome OR (95% CI)

Recurvatum/ Antecurvatum (Malalignment 5 to 10°) 0.00 (0.00, 39.00)

Varus/Valgus (Malalignment 5 to 10°) 0.00 (0.00, 2.34)

Limb length discrepancy at final review (up to 1 cm) 0.00 (0.00, 5.28)

Pain on final review 0.00 (0.00, 2.34)

Post-op loss of movement at hip 0.00 (0.00, 39.00)

Post-op loss of movement at knee 0.00 (0.00, 0.98)

1 Flexible Nailing External Fixation

Figure 31. Flexible Nailing vs. External Fixation - Complications(Barlas et al. 200626)

Outcome OR (95% CI)

Foot drop 1000.00 (0.03, 1000.00)

Early removal of nail 1000.00 (0.03, 1000.00)

Superficial infection 0.41 (0.06, 2.41)

Deep infection 0.00 (0.00, 39.00)

Refracture 0.00 (0.00, 5.28)

1 Flexible Nailing External Fixation

PREVIOUSLY PUBLISHED SYSTEMATIC REVIEWS Two previous systematic reviews21,23 concluded that early spica casting was associated with shorter inpatient hospital stays and fewer adverse events than traction. One review23 concluded that flexible nails reduced the malunion and adverse event rate compared to external fixation, and that external fixation reduced the maluion rate compared to early spica casting. This review also concluded that dynamic external fixation had a lower total adverse event rate compared to static external fixation, and that operative treatment reduced the malunion and total adverse event rates compared to nonoperative treatment. Both of these reviews, however, were not specific to the population of interest for this recommendation, so we did not include them in our systematic review.

Grade of Recommendation: Limited

Figures relevant to this recommendation are: Figure 32 - Figure 34 Tables relevant to this recommendation are: Table 12- Table 16

RATIONALE Skeletally immature patients are at increased risk for avascular necrosis of the femoral head when piriformis or near piriformis fossa entry nails are used. The rate of this potentially devastating complication is at least 4%.38 Every effort should be made to decrease the risk of avascular necrosis.

Fracture patterns that compromise post-reduction stability (i.e. axial and / or angular stability) as well as heavier patients may stimulate the surgeon to choose rigid trochanteric entry nailing or submuscular plating over flexible intramedullary nailing. One Low quality study demonstrated a five times higher risk of poor outcomes for flexible nailing in patients whose weight met or exceeded 49 kg (108 lbs).27 In the expert opinion of the work group, external fixation is another option in the older patient with an unstable fracture pattern, but its significantly higher complication rates, as demonstrated in other age groups,23,26 make it less desirable than rigid trochanteric entry nailing or submuscular plating.

SUPPORTING EVIDENCE One High Quality and four Low quality studies addressed this recommendation. The High Quality study39 compared nonoperative treatment, mainly traction and cast bracing, to closed intramedullary nailing. Of the 20 patients (21 fractures) in the operative group, 16 were treated with piriformis entry rigid nailing. There was a statistically significant difference in favor of intramedullary nailing for two outcomes, time to healing and malunion. There were no other statistically significant differences between the two groups.

Of the four Low quality studies, one investigated flexible nailing,27 one investigated rigid trochanteric entry nailing, 38 one investigated near piriformis entry rigid nailing,38,40 and one investigated submuscular plating of comminuted fractures.41

The study of flexible nailing27 also compared the weight of patients with an excellent or satisfactory outcome to the weight of patients with a poor outcome. Forty percent (40%) of the patients in this study were at least 11 years old. The 15 kg difference in mean weight between patients with a poor outcome and those with an excellent or satisfactory

outcome was statistically significant according to the author’s calculations (p=.003). Moreover, using a cut-off point of 49 kg, heavier patients were about five times more likely than lighter patients to have poor outcomes. However, the investigators found that weight did not independently predict a poor outcome when age was also included in a logistic regression model. The investigators also found that the weight cut-off point had 78.5% specificity and 59% sensitivity for detecting a poor outcome.

Table 12. Flexible Intramedullary Nailing and Patients’ Weight Mean weight Mean weight (poor Treatment n (excellent/satisfactory p-value outcome) outcome) Titanium 54 kg (range 22.3 to 222 39 kg (range 17 to 95.2) 0.003 Elastic Nailing 95.2)

Table 13. Traction vs. Piriformis Entry Rigid Nailing (Herndon et al.39)

Mean % % Outcome Duration n Difference (Rigid Favors (Traction) (95% CI) Nails)

Healing 1.5 (0.5, 2.5) n/a n/a IM Nailing (weeks) Malunion 29.0% 0.0% IM Nailing Shortening 20.8% 0.0% N/S >2cm Varus >10° 12.5% 0.0% N/S Valgus >10° 4.2% 0.0% N/S Anterior angle (<1 to 7 yrs. 8.3% 0.0% N/S >20° 44 follow up) Pressure sore n/a 4.2% 0.0% N/S Pin track 4.2% 0.0% N/S infection Limp 8.3% 0.0% N/S Second 8.3% 0.0% N/S Surgery Growth plate 0.0% 0.0% N/S arrest *N/S = no significant difference

Figure 32. Titanium Elastic Nailing Outcomes Among Age 11+ (Moroz et al.27)

100%

80% 55% 60%

29% 40%

% of% Patients 16% 20%

0% Excellent Satisfactory Poor Outcome

* AAOS computed the 95% confidence intervals from published data

Table 14. Rigid Trochanteric Entry Nailing Outcomes (Kanellopoulos et al.40) Outcome Duration n Mean % Secondary Healing n/a 20 9 weeks (8-13) n/a Weight Bearing (full) 6 weeks 20 n/a 80% Full Range of 6 weeks 20 n/a 100% Motion Return to Preinjury 29 months 20 n/a 100% Activity Limp 29 months 20 n/a 0% Delayed or 13 weeks 20 n/a 0% Nonunion Deep infections 29 months 20 n/a 0% Hip Osteonecrosis 29 months 20 n/a 0%

Table 15. Rigid Near Piriformis Entry Nailing Outcomes (Buford et al.38) Outcome Duration n Mean % Time to healing n/a 54 6 weeks n/a Gait disturbance 20 months 54 n/a 0% Hip pain 20 months 54 n/a 0% Significant leg length 20 months 54 n/a 0% discrepancies Nonunion 20 months 54 n/a 0% Infection 20 months 54 n/a 0% Subclinical avascular 20 months 54 n/a 4% necrosis Postoperative 20 months 54 n/a 0% nerve palsies Acetabular 20 months 54 n/a 0% dysplasia Refracture 20 months 54 n/a 2% through nail site

Table 16. Bridge Plating Outcomes (Agus et al.41) Outcome Duration n Mean (95% CI) % Time to grade 2 callus (weeks) n/a 10 9.1 (7.7, 10.5) n/a Complete radiographic healing n/a 10 13.4 (11.4, 15.4) n/a time (weeks) Broken plates 4 years 10 n/a 0.0% Refractures 4 years 10 n/a 0.0% Femoral length inequality (cm) 4 years 10 0.6 (0.4, 0.8) n/a Increased torsion 4 years 10 n/a 50.0% Decreased torsion 4 years 10 n/a 50.0% Torsion diff b/w injured/uninjured 4 years 10 4.5° (0, 9.7) n/a limb (absolute value) Limp 4 years 10 n/a 0.0%

Figure 33. Bridge Plating - Percentage of Patients with Frontal Plane Angulation (Agus et al.41)

100.0%

80.0%

60.0%

40.0%

20.0%

0.0% Post-operative 4 years

*AAOS computed the 95% confidence intervals from published data

Figure 34. Bridge Plating -Percentage of Patients with Sagittal Plane Angulation (Agus et al.41)

100.0%

80.0%

60.0%

40.0%

20.0%

0.0% Post-operative 4 years

* AAOS computed the 95% confidence intervals from published data

PREVIOUSLY PUBLISHED SYSTEMATIC REVIEWS A previous systematic review23 concluded that intramedullary nailing resulted in fewer malunions and adverse events than traction or subsequent casting. This review, however, was not specific to the population of interest for this recommendation, so we did not include it in our systematic review.

PAIN CONTROL Limited evidence supports regional pain management for patient comfort peri- operatively.

Grade of Recommendation: Limited

Figures relevant to this recommendation are: Figure 35 - Figure 38 Tables relevant to this recommendation are: Table 17

RATIONALE We identified one High quality study45 of a hematoma block and one Low quality study46 of a femoral nerve block, both of which were effective at reducing pain. In the expert opinion of the work group, the risks associated with regional pain management, such as femoral nerve neuritis and the complications associated with epidural anesthesia in lower extremity fractures (missed compartment syndrome), are less than with oral or IV systemic medicines.

SUPPORTING EVIDENCE One Moderate Quality study45 investigating a hematoma block and one Low quality case series46 investigating a femoral nerve block addressed this recommendation. The High quality study compared patients who received a bupivacaine hematoma block after elastic nail fixation to patients who did not receive a hematoma block. Pain scale scores were not reported; however, patients who received a hematoma block received their first post- operative narcotic dose a mean of 5 hours later than patients in the control group (p = .008).

In the Low quality case series, the authors reported that the nerve block was effective at reducing pain (Figure 38). The onset of analgesia occurred in 8.0 ± 3.5 minutes. The pain scale used in this study ranges from 0 (calm, no spontaneous pain or during handling, radiographs, or traction installation) to 4 (child is crying, major tachycardia (>60% normal rate in consideration to age) and high blood pressure, handling impossible). Table 17 lists the complications in this study.

Figure 35. Hematoma Block vs. Control - Time until First Post-Operative Narcotic Dose

Mean

Outcome Difference (95% CI)

Hours until first 5.22 (1.47, 8.97)

post-operative narcotic dose

0 No Hematoma Block Hematoma Block

Figure 36. Hematoma Block vs. Control - Post-Operative Narcotic Requirement

Mean

Outcome Difference (95% CI)

Narcotic equivalent requirement in 0.04 (-0.03, 0.11)

first 6 post-operative hours (Eq/kg)

0 No Hematoma Block Hematoma Block

Figure 37. Hematoma Block vs. Control - Binary Outcomes

Outcome Odds Ratio (95% CI)

Received narcotic pain medication 0.15 (0.00, 1.43) within first 2 post-operative hours

Mild oxygen desaturation in 0.00 (0.00, 66.00) first 12 post-operative hours

Urinary retention 1000.00 (0.04, 1000.00)

1 Hematoma Block No Hematoma Block

Figure 38. Femoral Nerve Block – Pain Relief

1 Pain Grade Pain

0 Before After

*p<.001 (AAOS calculation); AAOS computed the 95% confidence intervals from published data

Table 17. Femoral Nerve Block Complications Outcome n % Failed block 7% Femoral artery puncture 7% ECG changes 0% Seizure 14 0% Respiratory Rate Abnormality 0% Adverse Sequelae 0% Neurologic Abnormality (at discharge) 0%

3 Before Pain Grade

PREVIOUSLY PUBLISHED SYSTEMATIC REVIEWS A previous systematic review 47 concluded that femoral nerve block effectively reduces pain in children with femoral shaft fractures. Although the stated subject of this systematic review was children, two of the three included studies included adults. Therefore, we did not include it in our systematic review.

WATERPROOF CASTING Limited evidence supports waterproof cast liners for spica casts are an option for use in children diagnosed with pediatric diaphyseal femur fractures.

Grade of Recommendation: Limited

Figures relevant to this recommendation are: Figure 39

RATIONALE Waterproof cast liners are often used when applying a spica cast for the management of femur fractures in children in order to improve ease of care.

We identified one High Quality study48 that addressed the use of waterproof liners in spica casts. Use of a waterproof liner was associated with significantly fewer skin problems and unexpected cast changes. However, in this study spica casts were used for the management of developmental dysplasia of the hip, not specifically for diaphyseal femur fractures. In addition, other outcomes such as impact on family and financial considerations were not studied. Waterproof liners may make cast care easier for the family, thus decreasing the overall impact of treatment on family functioning. Cast liners add increased cost to overall management. Nevertheless, the patient ages were similar to the patient ages for spica cast management of diaphyseal femur fractures and the findings should be able to be extrapolated. The overall benefit in terms of skin problems, unplanned cast changes, and ease of care for the family likely obviates the increased costs from the use of waterproof cast liners in the expert opinion of the physician work group.

SUPPORTING EVIDENCE One High Quality study48 addressed this recommendation. In this study, however, hip spica casts were applied to treat conditions other than diaphyseal femur fractures, such as developmental dysplasia. The study compared the use of hip spica casts with and without a waterproof liner. The use of a waterproof liner was associated with significantly fewer occurrences of skin excoriation and unplanned cast changes.

Figure 39. Waterproof Liner vs. No Waterproof Liner

Events, Events, No

Outcome OR (95% CI) Liner Liner

Skin Excoriation 0.06 (0.01, 0.54) 1/36 11/36

Unplanned Cast Changes (per cast) 0.20 (0.04, 0.93) 2/70 10/77

1 Waterproof Liner No Liner

Future Research The quality of scientific data regarding the management of femur fractures in children is clearly lacking. Controversy exists regarding the optimal management of pediatric femur fractures. A multitude of treatment options exist including Pavlik harness, spica casting, traction, external fixation, flexible intramedullary nailing, rigid intramedullary nailing, and bridge plating. Properly designed randomized clinical trials comparing treatment options are necessary to determine optimal treatment. These trials would benefit from being multicenter trials in terms of accrual of patients and external validity.

Specific trials which would be helpful include:

1. Delayed spica casting versus immediate spica casting for femur fractures in children 6 months – 6 years old. 2. Flexible intramedullary nailing versus immediate spica casting for femur fractures in children 5 and 6 years old, and even children younger than 5-6 years of age. 3. External fixation versus bridge plating versus elastic nails versus rigid trochanteric nails for length unstable femur fractures in children 6 years old – skeletal maturity. 4. Flexible intramedullary nailing versus rigid intramedullary nailing versus bridge plating for femur fractures in children 6 years old – skeletal maturity.

Intermediate outcome measures are often used in studies regarding pediatric femur fractures such as radiographic parameters. Functional outcome measures and later development of osteoarthritis are difficult to measure and have a long time course. However, the relationship between commonly accepted radiographic measures of malunion and functional outcome or later development of problems is not clear. Further research to validate accepted radiographic standards of malunion would be extremely valuable. Also the inclusion of family function outcomes may improve recommendations

for those younger patients that may either get intramedullary nailing versus immediate spica casting.

V. APPENDIXES

APPENDIX I AAOS BODIES THAT APPROVED THE 2015 GUIDELINE REISSUE

This final guideline draft must be approved by the AAOS Committee on Evidence Based Quality and Value, the AAOS Council on Research and Quality, and the AAOS Board of Directors. These decision-making bodies are invited to provide comments during the review process for consideration by the work group but are not designated to modify the contents of the guideline. Their charge is to approve or reject its publication by majority vote.

Committee on Evidence Based Quality and Value - April 18, 2015 The committee on Evidence Based Quality and Value (EBQV) consists of twenty AAOS members who implement evidence-based quality initiatives such as clinical practice guidelines (CPGs) and appropriate use criteria (AUCs). They also oversee the dissemination of related educational materials and promote the utilization of orthopaedic value products by the Academy’s leadership and its members.

Council on Research and Quality – May 8, 2015

The Council on Research and Quality promotes ethically and scientifically sound clinical and translational research to sustain patient care in musculoskeletal disorders. The Council also serves as the primary resource for educating its members, the public, and public policy makers regarding evidenced-based medical practice, orthopaedic devices and biologics, regulatory pathways and standards development, patient safety, occupational health, technology assessment, and other related important errors.

The Council is comprised of the chairs of the committees on Biological Implants, Biomedical Engineering, Occupational Health and Workers’ Compensation, Patient Safety, Research Development, U.S. Bone and Joint Decade, and chair and Appropriate Use Criteria and Clinical Practice Guideline section leaders of the Evidence Based Quality and Value committee. Also on the Council are the second vice-president, three members at large, and representatives of the Diversity Advisory Board, Women's Health Issues Advisory Board, Board of Specialty Societies (BOS), Board of Councilors (BOC), Communications Cabinet, Orthopaedic Research Society (ORS), Orthopedic Research and Education Foundation (OREF).

Board of Directors – June 5, 2015 The 17 member Board of Directors manage the affairs of the AAOS, set policy, and oversee the Strategic Plan.

The 2009 CPG was approved by the AAOS Guidelines and Technology Oversight Committee, the AAOS Evidence Based Practice Committee, the AAOS Council on Research, Quality Assessment and Technology, and the AAOS Board of Directors

APPENDIX II LITERATURE SEARCHES

The search for eligible literature began with a search of the following databases on May 8, 2008, and updated on October 6, 2008, and November 27, 2013:  PubMed (from 1966 through November 27, 2013)  EMBASE (from 1966 through November 27, 2013)  CINAHL (from 1982 through November 27, 2013)  The Cochrane Central Register of Controlled Trials (through November 27, 2013)

The original search (after removal of duplicates) yielded 1181 articles, of which 274 were retrieved and evaluated. The full search strategies are listed below. The updated search conducted in November 2013 yielded an additional 384 articles published after the original search.

All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base. In addition, the bibliographies of recent systematic reviews and other review articles were searched for potentially relevant citations.

GENERAL SEARCH PubMed was searched using the following strategy: (diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh) NOT "comment"[Publication Type] NOT "editorial"[Publication Type] NOT "letter"[Publication Type] NOT "Addresses"[Publication Type] NOT "News"[Publication Type] NOT "Newspaper Article"[Publication Type] AND (("1966/1/1"[EDat]:"2008/10/01"[EDat]) AND (Humans[Mesh]) AND (English[lang]) AND ((infant[MeSH] OR child[MeSH] OR adolescent[MeSH])) )

EMBASE was searched using the following strategy: (diaphyseal OR ('diaphysis'/exp OR 'diaphysis') OR shaft OR diaphysial) AND ('fracture'/exp OR 'fracture') AND (('femur'/exp OR 'femur') OR femoral OR ('thigh'/exp OR 'thigh')) AND ([article]/lim OR [review]/lim) AND [english]/lim AND [humans]/lim AND ([infant]/lim OR [child]/lim OR [adolescent]/lim) AND [embase]/lim AND [1966- 2008]/py

CINAHL was searched using the following strategy: (diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh)

Cochrane Central Register of Controlled Trials was searched using the following strategy: (diaphyseal OR diaphysis OR shaft OR diaphysial) AND fracture AND (femur OR femoral OR thigh)

WATERPROOF CAST LINER SEARCH A search for literature pertaining to cast liners began with a search of the following databases on August 6, 2008, and updated on October 7, 2008, and November 27, 2013:

PubMed was searched using the following strategy: cast AND (liner OR waterproof)

EMBASE was searched using the following strategy: cast AND (liner OR waterproof) AND [english]/lim AND [humans]/lim AND [embase]/lim

CINAHL was searched using the following strategy: Cast AND (liner OR waterproof)

Cochrane Central Register of Controlled Trials was searched using the following strategy: Cast AND (liner OR waterproof)

APPENDIX III STUDY ATTRITION FLOWCHARTS

ORIGINAL 2008 LITERATURE SEARCH FLOWCHART 1153 citations identified by literature searches

883 citations not retrieved

270 articles retrieved for full-text review

224 articles did not meet inclusion criteria

46 articles considered for guideline recommendations

15 articles excluded

31 articles included (see individual guideline recommendation inclusion/exclusion list)

UPDATED 2013 LITERATURE SEARCH FLOWCHART

WATERPROOF CAST LINER SEARCH FLOWCHART 48 citations identified by literature searches

43 citations not retrieved

5 articles retrieved for full-text review

4 articles did not meet inclusion criteria

1 article included

APPENDIX IV DATA EXTRACTION ELEMENTS

The data elements below were extracted into electronic forms in Microsoft® Excel from published studies. The extracted information includes:

Study Characteristics (for all relevant outcomes in a study)  methods of randomization and allocation  use of blinding (patient, caregiver, evaluator)  funding source/conflict of interest  duration of the study  number of subjects and follow-up percentage  experimental and control groups  a priori power analysis

Patient Characteristics (for all treatment groups in a study)  patient inclusion/exclusion criteria  age  weight  surgical complications  adverse events

Results (for all relevant outcomes in a study)  duration at which outcome measure was evaluated  mean value of statistic reported (for dichotomous results)  mean value of measure and value of dispersion (for continuous results)  statistical test p-value

APPENDIX V FORM FOR ASSIGNING GRADE OF RECOMMENDATION (INTERVENTIONS)

GUIDELINE RECOMMENDATION______

PRELIMINARY GRADE OF RECOMMENDATION:______

STEP 1: LIST BENEFITS AND HARMS

Please list the benefits (as demonstrated by the systematic review) of the intervention

Please list the harms (as demonstrated by the systematic review) of the intervention

Please list the benefits for which the systematic review is not definitive

Please list the harms for which the systematic review is not definitive

STEP 2: IDENTIFY CRITICAL OUTCOMES

Please circle the above outcomes that are critical for determining whether the intervention is beneficial and whether it is harmful

Are data about critical outcomes lacking to such a degree that you would lower the preliminary grade of the recommendation?

What is the resulting grade of recommendation?

STEP 3: EVALUATE APPLICABILITY OF THE EVIDENCE

Is the applicability of the evidence for any of the critical outcomes so low that substantially worse results are likely to be obtained in actual clinical practice?

Please list the critical outcomes backed by evidence of doubtful applicability:

Should the grade of recommendation be lowered because of low applicability?

What is the resulting grade of recommendation?

STEP 4: BALANCE BENEFITS AND HARMS

Are there trade-offs between benefits and harms that alter the grade of recommendation obtained in STEP 3?

What is the resulting grade of recommendation?

STEP 5 CONSIDER STRENGTH OF EVIDENCE

Does the strength of the existing evidence alter the grade of recommendation obtained in STEP 4?

What is the resulting grade of recommendation?

NOTE: Because we are not performing a formal cost analyses, you should only consider costs if their impact is substantial.

APPENDIX VI PEER REVIEW PANEL FOR THE ORIGINAL 2009 GUIDELINE Participation in the AAOS peer review process does not constitute an endorsement of this guideline by the participating organization.

Peer review of the draft guideline is completed by an outside Peer Review Panel. Outside peer reviewers are solicited for each AAOS guideline and consist of experts in the guideline’s topic area. These experts represent professional societies other than AAOS and are nominated by the guideline Work Group prior to beginning work on the guideline. For this guideline, five outside peer review organizations were invited to review the draft guideline and all supporting documentation. All five societies participated in the review of the Treatment of Pediatric Diaphyseal Femur Fractures guideline draft and four consented to be listed as a peer review organization in this appendix. One organization did not give explicit consent that the organization name could be listed in this publication. The organizations that reviewed the document and consented to publication are listed below:

American Academy of Pediatrics, Section on Orthopaedics

European Paediatric Orthopaedic Society

Orthopaedic Trauma Association

American Osteopathic Academy of Orthopedics

Individuals who participated in the peer review of this document and gave their consent to be listed as reviewers of this document are:

James Breivis, MD, San Francisco, CA Blair C. Filler MD, Los Angeles, CA J. Eric Gordon MD, St. Louis MS Michael Heggeness MD, Houston, TX Harvey Insler MD, Erie, PA John Kirkpatrick MD, Jacksonville, FL Pierre Lascombes MD, Nancy France David A. Podenswa MD, Dallas, TX Charles A Reitman MD, Houston, TX Debra K. Spatz, D.O, Prince Frederick, MD

Again, participation in the AAOS guideline peer review process does not constitute an endorsement of the guideline by the participating organizations or the individuals listed above.

PUBLIC COMMENTARY FOR ORIGINAL 2009 GUIDELINE A period of public commentary follows the peer review of the draft guideline. If significant non-editorial changes are made to the document as a result of public commentary, these changes are also documented and forwarded to the AAOS bodies that approve the final guideline. Public commentators who gave explicit consent to be listed in this document include the following:

Participation in the AAOS guideline public commentary review process does not constitute an endorsement of the guideline by the participating organizations or the individual listed nor does it is any way imply the reviewer supports this document.

Jeffrey Anglen MD, Indianapolis, IN Howard R. Epps MD, Houston TX M. Bradford Henley MD MBA, Seattle WA William C McMaster MD, Orange, CA Jack R. Steel MD, Huntington WV

J. Mark Melhorn MD, Wichita, KS on behalf of: The American Academy of Disability Evaluating Physicians

APPENDIX VII STRUCTURED PEER REVIEW FORM

Reviewer Information:

Name of Reviewer______Address______City______State______Zip Code______Phone ______Fax ______E-mail______

Specialty Area/Discipline: ______Work setting: ______Credentials: ______

May we list you as a Peer Reviewer in the final Guidelines? Yes No

Are you reviewing this guideline as Yes No a representative of a professional society?

If yes, may we list your society as a reviewer Yes No of this guideline?

Reviewer Instructions Please read and review this Draft Clinical Practice Guideline and its associated Technical Report with particular focus on your area of expertise. Your responses are confidential and will be used only to assess the validity, clarity, and accuracy of the interpretation of the evidence. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report.

If you need more space than is provided, please attach additional pages. Please complete and return this form electronically to [email protected] or fax the form back to Jan Weis at (847) 823-9769.

Thank you in advance for your time in completing this form and giving us your feedback. We value your input and greatly appreciate your efforts. Please send the completed form and comments by Month, Day, Year

COMMENTS Please provide a brief explanation of both your positive and negative answers in the preceding section. If applicable, please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report

OVERALL ASSESSMENT

Would you recommend these guidelines for use in practice? (check one)

Strongly recommend ______

Recommend (with provisions or alterations) ______

Would not recommend ______

Unsure ______

COMMENTS: Please provide the reason(s) for your recommendation.

APPENDIX VIII INTERPRETING THE FOREST PLOTS49 Throughout the guideline we use descriptive diagrams or forest plots to present data from studies comparing the differences in outcomes between two treatment groups. In this guideline there are no meta-analyses (combining results of multiple studies into a single estimate of overall effect), so each point and corresponding horizontal line on a sample plot should be viewed independently. In the example below, the odds ratio is the effect measure used to depict differences in outcomes between the two treatment groups of a study. In other forest plots, the point can refer to other summary measures (such as the mean difference or relative risk). The horizontal line running through each point represents the 95% confidence interval for that point. In this graph, the solid vertical line represents “no effect” where the Odds Ratio, OR, is equal to one. When mean differences are portrayed, the vertical line of no effect is at zero.

For example, in the figure below the odds of a patient experiencing Outcome 1 are 5.9 times greater for patients who received Treatment B than for patients who received Treatment A.. This result is statistically significant because the 95% Confidence Interval does not cross the “no effect” line. In general, the plots are arranged such that results to the left of the “no effect” line favor Treatment A while results to the right favor Treatment B. In the example below, the odds ratio for Outcome 1 favors Treatment B, the odds ratio for Outcome 3 favors Treatment A, and the odds ratio for Outcome 2 does not favor either treatment because the 95% CI crosses the “no effect” line (i.e. the difference is not statistically significant).

Sample Plot

Outcome Odds Ratio (95% CI)

Outcome 1 5.90 (3.38, 10.29)

Outcome 2 0.72 (0.43, 1.19)

Outcome 3 0.11 (0.06, 0.20)

1 GroupTreatment A A GroupTreatment B B

DESCRIPTION OF SYMBOLS USED IN FIGURES AND TABLES Symbol Description Odds Ratio = The odds in Group B divided by the odds in Group A, where the odds is OR the probability of the outcome occurring divided by the probability of the outcome not occurring. 95% Confidence Interval = A measure of uncertainty of the point estimate: if the trial 95% CI were repeated an infinite number of times, then the 95% CI calculated for each trial would contain the true effect 95% of the time. An arrow in a forest plot indicates that the 95% confidence interval continues beyond the range of the graph. An open circle in a Summary of Evidence Table indicates that the result is not ○ statistically significant. A filled-in circle in a Summary of Evidence Table indicates that the result is ● fn statistically significant in favor of the listed treatment (in this example, in favor of fn = flexible nails)

APPENDIX IX CONFLICT OF INTEREST All members of the AAOS work group disclosed their conflicts of interest prior to the development of the recommendations for this guideline. Conflicts of interest are disclosed in writing with the American Academy of Orthopaedic Surgeons via a private on-line reporting database and also verbally at the recommendation approval meeting. Members of all AAOS Work Groups are required to disclose their conflicts of interest at the same level and depth of detail as the AAOS Board of Directors.

AAOS DISCLOSURE PROGRAM INFORMATION

R Dale Blasier, MD (Little Rock, AR): 4 (Synthes); 7 (Synthes). Submitted on: 04/23/2008.

Michael J Goldberg, MD: 2 (Journal of Pediatric Orthopedics; Journal of Children's Orthopaedics). Submitted on: 12/11/2007.

Mininder S Kocher, MD (Boston, MA): 1 (Pediatric Orthopaedic Society of North America); 5A (Biomet; Regen Biologics; Smith & Nephew); 7 (CONMED Linvatec); 9 (Saunders/Mosby-Elsevier). Submitted on: 05/27/2008.

Scott J Luhmann, MD (Saint Louis, MO): 4 (Medtronic Sofamor Danek; Stryker); 5A (Medtronic Sofamor Danek); 7 (Medtronic Sofamor Danek). Submitted on: 08/05/2008.

Travis Matheney, MD (Boston, MA): (n). Submitted on: 10/29/2008

Charles T Mehlman, DO (Cincinnati, OH): 2 (Journal of Bone and Joint Surgery - American; Journal of Orthopaedics and Traumatology; Journal of Pediatric Orthopedics; Saunders/Mosby-Elsevier; Wolters Kluwer Health - Lippincott Williams & Wilkins; eMedicine (Orthopaedic Surgery); Journal Children's Orthopaedics (EPOS); The Orthopod (JAOAO); The Spine Journal (NASS)); 5B (Stryker); 7 (DePuy, A Johnson & Johnson Company; Medtronic Sofamor Danek; National Institutes of Health (NIAMS & NICHD); Synthes; University Cincinnati); 8 (Eli Lilly; Zimmer). Submitted on: 04/08/2008.

James O Sanders, MD (Rochester, NY): 7 (Medtronic Sofamor Danek; K2M); 8 (Abbott; Biomedical Enterprises). Submitted on: 07/30/2008.

David M Scher, MD (New York, NY): 1 (American Academy for Cerebral Palsy and Developmental Medicine; Pediatric Orthopaedic Club of New York); 2 (Hospital for Special Surgery Journal). Submitted on: 03/28/2008.

Ernest L Sink, MD (Aurora, CO): 1 (Pediatric Orthopaedic Society of North America); 2 (Orthopedics); 4 (Biomet); 5B (Biomet). Submitted on: 04/15/2008.

William Charles Watters III, MD: 1 (North American Spine Society; Work Loss Data Institute); 2 (The Spine Journal); 5A (Stryker; Intrinsic Therapeutics; MeKessen Health Care Solutions). Submitted on: 10/09/2007 at 08:09 PM and last confirmed as accurate on 04/23/2008.

Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts. 1=Board member/owner/officer/committee appointments; 2= Medical/Orthopaedic Publications; 3= Royalties; 4= Speakers bureau/paid presentations;5A= Paid consultant; 5B= Unpaid consultant; 6= Research or institutional support from a publisher; 7= Research or institutional support from a company or supplier; 8= Stock or Stock Options; 9= Other financial/material support from a publisher; 10= Other financial/material support from a company or supplier.

APPENDIX X REFERENCES (1) Hinton RY, Lincoln A, Crockett MM, Sponseller P, Smith G. Fractures of the femoral shaft in children. Incidence, mechanisms, and sociodemographic risk factors. J Bone Joint Surg Am. 1999;81:500-509.

(2) Rewers A, Hedegaard H, Lezotte D et al. Childhood femur fractures, associated injuries, and sociodemographic risk factors: a population-based study. Pediatrics. 2005;115:e543-e552.

(3) Sahlin Y. Occurrence of fractures in a defined population: a 1-year study. Injury. 1990;21:158-160.

(4) McCartney D, Hinton A, Heinrich SD. Operative stabilization of pediatric femur fractures. Orthop Clin North Am. 1994;25:635-650.

(5) Coyte PC, Bronskill SE, Hirji ZZ, Daigle-Takacs G, Trerise BS, Wright JG. Economic evaluation of 2 treatments for pediatric femoral shaft fractures. Clin Orthop Relat Res. 1997;205-215.

(6) Morton L, Bridgman S, Dwyer J, Theis J. Interventions for treating femoral shaft fractures in children and adolescents (Protocol). Cochrane Database of Systematic Reviews. 2002;1-8.

(7) Femoral Shaft Fractures Guideline Team. Evidence-based care guideline for medical management of Femoral Shaft Fractures. Guideline 22 , 1-19. 2006. Cincinnati Children's Hospital Medical Center. Ref Type: Electronic Citation

(8) Cook D.J., Mulrow CD, Haynes RB. Systematic Reviews:synthesis of best evidence for clinical decisions. Ann Intern Med. 1997;126:376-380.

(9) Mulrow C.D., Cook D.J., Davidoff F. Systematic Reviews:critical links in the great chain of evidence. Ann Intern Med. 1997;126:389-391.

(10) Bucher H.C., Guyatt G.H., Cook D.J., Holbrook A., McAlister F.A. Users' Guides to the Medical Literature. JAMA. 1999;282.

(11) Robinson KA, Dickerson K. Development of a highly sensitive search strategy for the retrieval of reports of controlled trials using PubMed. Int Journal of Epidemiology. 2002;31:150-153.

(12) GRADE Working Group. Grading quality of evidence and strength of recommendations. BMJ. 2004;328.

(13) Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005;5:13.

(14) Wilson E. Probable inference, the law of succession, and statistical inference. Journal of the American Statistical Association. 1927;22:209-212.

(15) Akbarnia BM, Torg JSM, Kirkpatrick JM, Sussman SM. Manifestations of the Battered-Child Syndrome. The Journal of Bone and Joint Surgery. 1974;56- A:1159-1166.

(16) Miettinen H, Makela EA, Vainio J. The incidence and causative factors responsible for femoral shaft fractures in children. Ann Chir Gynaecol. 1991;80:392-395.

(17) Podeszwa DA, Mooney JF, III, Cramer KE, Mendelow MJ. Comparison of Pavlik harness application and immediate spica casting for femur fractures in infants. J Pediatr Orthop. 2004;24:460-462.

(18) Stannard JP, Christensen KP, Wilkins KE. Femur fractures in infants: a new therapeutic approach. J Pediatr Orthop. 1995;15:461-466.

(19) Rasool MN, Govender S, Naidoo KS. Treatment of femoral shaft fractures in children by early spica casting. S Afr Med J. 1989;76:96-99.

(20) Burton VW, Fordyce AJ. Immobilization of femoral shaft fractures in children aged 2-10 years. Injury. 1972;4:47-53.

(21) Wright JG. The treatment of femoral shaft fractures in children: a systematic overview and critical appraisal of the literature. Can J Surg. 2000;43:180-189.

(22) Wright JG, Wang EE, Owen JL et al. Treatments for paediatric femoral fractures: a randomised trial. Lancet. 2005;365:1153-1158.

(23) Poolman RW, Kocher MS, Bhandari M. Pediatric femoral fractures: a systematic review of 2422 cases. J Orthop Trauma. 2006;20:648-654.

(24) Flynn JM, Luedtke LM, Ganley TJ et al. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am. 2004;86-A:770-777.

(25) Buechsenschuetz KE, Mehlman CT, Shaw KJ, Crawford AH, Immerman EB. Femoral shaft fractures in children: traction and casting versus elastic stable intramedullary nailing. J Trauma. 2002;53:914-921.

(26) Barlas K, Beg H. Flexible intramedullary nailing versus external fixation of paediatric femoral fractures. Acta Orthop Belg. 2006;72:159-163.

(27) Moroz LA, Launay F, Kocher MS et al. Titanium elastic nailing of fractures of the femur in children. Predictors of complications and poor outcome. J Bone Joint Surg Br. 2006;88:1361-1366.

(28) Domb BG, Sponseller PD, Ain M, Miller NH. Comparison of dynamic versus static external fixation for pediatric femur fractures. J Pediatr Orthop. 2002;22:428-430.

(29) Mehdinasab SA, Nejad SAM, Sarrafan N. Short term outcome of treatment of femoral shaft fractures in children by two methods: Traction plus casting, versus intramedullary pin fixation - A comparative study. Pak J Med Sci. 2008;24:147- 151.

(30) Ali M, Raza A. Union and complications after Thomas splint and early hip spica for femoral shaft fractures in children. J Coll Physicians Surg Pak. 2005;15:799- 801.

(31) Curtis JF, Killian JT, Alonso JE. Improved treatment of femoral shaft fractures in children utilizing the pontoon spica cast: a long-term follow-up. J Pediatr Orthop. 1995;15:36-40.

(32) Nork SE, Hoffinger SA. Skeletal traction versus external fixation for pediatric femoral shaft fractures: a comparison of hospital costs and charges. J Orthop Trauma. 1998;12:563-568.

(33) Song HR, Oh CW, Shin HD et al. Treatment of femoral shaft fractures in young children: comparison between conservative treatment and retrograde flexible nailing. J Pediatr Orthop B. 2004;13:275-280.

(34) Hedin H, Borgquist L, Larsson S. A cost analysis of three methods of treating femoral shaft fractures in children: a comparison of traction in hospital, traction in hospital/home and external fixation. Acta Orthop Scand. 2004;75:241-248.

(35) Rasit AH, Mohammad AW, Pan KL. The pattern of femoral diaphyseal fractures in children admitted in Sarawak General Hospital. Med J Malaysia. 2006;61 Suppl A:79-82.

(36) Sturdee SW, Templeton PA, Dahabreh Z, Cullen E, Giannoudis PV. Femoral fractures in children, is early interventional treatment beneficial? Injury. 2007;38:937-944.

(37) Wall EJ, Jain V, Vora V, Mehlman CT, Crawford AH. Complications of titanium and stainless steel elastic nail fixation of pediatric femoral fractures. J Bone Joint Surg Am. 2008;90:1305-1313.

(38) Buford D, Jr., Christensen K, Weatherall P. Intramedullary nailing of femoral fractures in adolescents. Clin Orthop Relat Res. 1998;85-89.

(39) Herndon WA, Mahnken RF, Yngve DA, Sullivan JA. Management of femoral shaft fractures in the adolescent. J Pediatr Orthop. 1989;9:29-32.

(40) Kanellopoulos AD, Yiannakopoulos CK, Soucacos PN. Closed, locked intramedullary nailing of pediatric femoral shaft fractures through the tip of the greater trochanter. J Trauma. 2006;60:217-222.

(41) Agus H, Kalenderer O, Eryanilmaz G, Omeroglu H. Biological internal fixation of comminuted femur shaft fractures by bridge plating in children. J Pediatr Orthop. 2003;23:184-189.

(42) Mazda K, Khairouni A, Pennecot GF, Bensahel H. Closed flexible intramedullary nailing of the femoral shaft fractures in children. J Pediatr Orthop B. 1997;6:198- 202.

(43) Cramer KE, Tornetta P, III, Spero CR, Alter S, Miraliakbar H, Teefey J. Ender rod fixation of femoral shaft fractures in children. Clin Orthop Relat Res. 2000;119-123.

(44) Hedin H, Hjorth K, Rehnberg L, Larsson S. External fixation of displaced femoral shaft fractures in children: a consecutive study of 98 fractures. J Orthop Trauma. 2003;17:250-256.

(45) Herrera JA, Wall EJ, Foad SL. Hematoma Block Reduces Narcotic Pain Medication after Femoral Elastic Nailing in Children. J Pediatr Orthop. 2004;24:254-256.

(46) Ronchi L, Rosenbaum D, Athouel A et al. Femoral nerve blockade in children using bupivacaine. Anesthesiology. 1989;70:622-624.

(47) Williams R, Wallman P. Towards evidence based emergency medicine: best BETs from the Manchester Royal Infirmary. Regional anaesthesia for femoral shaft fractures in children. J Accid Emerg Med. 2000;17:283-284.

(48) Wolff CR, James P. The prevention of skin excoriation under children's hip spica casts using the goretex pantaloon. J Pediatr Orthop. 1995;15:386-388.

(49) Oleckno W.A. Epidemiology Concepts and Methods. Long Grove, IL.: Waveland Press, Inc.; 2008.

(50) Shemshaki,H.R., Mousavi,H., Salehi,G., Eshaghi,M.A. Titanium elastic nailing versus hip spica cast in treatment of femoral-shaft fractures in children. J Orthop Traumatol. 2011/3; 1: 45-48

INCLUDED ARTICLES

Agus H, Kalenderer O, Eryanilmaz G, Omeroglu H. Biological internal fixation of comminuted femur shaft fractures by bridge plating in children. J Pediatr Orthop 2003 March;23(2):184-9.

Ali M, Raza A. Union and complications after Thomas splint and early hip spica for femoral shaft fractures in children. J Coll Physicians Surg Pak 2005 December;15(12):799-801.

Barlas K, Beg H. Flexible intramedullary nailing versus external fixation of paediatric femoral fractures. Acta Orthop Belg 2006 April;72(2):159-63.

Buechsenschuetz KE, Mehlman CT, Shaw KJ, Crawford AH, Immerman EB. Femoral shaft fractures in children: traction and casting versus elastic stable intramedullary nailing. J Trauma 2002 November;53(5):914-21.

Buford D, Jr., Christensen K, Weatherall P. Intramedullary nailing of femoral fractures in adolescents. Clin Orthop Relat Res 1998 May;(350):85-9.

Burton VW, Fordyce AJ. Immobilization of femoral shaft fractures in children aged 2-10 years. Injury 1972 August;4(1):47-53.

Cramer KE, Tornetta P, III, Spero CR, Alter S, Miraliakbar H, Teefey J. Ender rod fixation of femoral shaft fractures in children. Clin Orthop Relat Res 2000 July;(376):119-23.

Curtis JF, Killian JT, Alonso JE. Improved treatment of femoral shaft fractures in children utilizing the pontoon spica cast: a long-term follow-up. J Pediatr Orthop 1995 January;15(1):36-40.

Domb BG, Sponseller PD, Ain M, Miller NH. Comparison of dynamic versus static external fixation for pediatric femur fractures. J Pediatr Orthop 2002 July;22(4):428-30.

Flynn JM, Luedtke LM, Ganley TJ et al. Comparison of titanium elastic nails with traction and a spica cast to treat femoral fractures in children. J Bone Joint Surg Am 2004 April;86-A(4):770-7.

Hedin H, Hjorth K, Rehnberg L, Larsson S. External fixation of displaced femoral shaft fractures in children: a consecutive study of 98 fractures. J Orthop Trauma 2003 April;17(4):250-6.

Hedin H, Borgquist L, Larsson S. A cost analysis of three methods of treating femoral shaft fractures in children: a comparison of traction in hospital, traction in hospital/home and external fixation. Acta Orthop Scand 2004 June;75(3):241-8.

Herndon WA, Mahnken RF, Yngve DA, Sullivan JA. Management of femoral shaft fractures in the adolescent. J Pediatr Orthop 1989 January;9(1):29-32.

Herrera JA, Wall EJ, Foad SL. Hematoma Block Reduces Narcotic Pain Medication after Femoral Elastic Nailing in Children. J Pediatr Orthop 2004;24(3):254-6.

Hinton RY, Lincoln A, Crockett MM, Sponseller P, Smith G. Fractures of the femoral shaft in children. Incidence, mechanisms, and sociodemographic risk factors. J Bone Joint Surg Am 1999 April;81(4):500-9.

Kanellopoulos AD, Yiannakopoulos CK, Soucacos PN. Closed, locked intramedullary nailing of pediatric femoral shaft fractures through the tip of the greater trochanter. J Trauma 2006 January;60(1):217-22.

Mazda K, Khairouni A, Pennecot GF, Bensahel H. Closed flexible intramedullary nailing of the femoral shaft fractures in children. J Pediatr Orthop B 1997 July;6(3):198-202.

Mehdinasab SA, Nejad SAM, Sarrafan N. Short term outcome of treatment of femoral shaft fractures in children by two methods: Traction plus casting, versus intramedullary pin fixation - A comparative study. Pak J Med Sci 2008;24(1):147-51.

Miettinen H, Makela EA, Vainio J. The incidence and causative factors responsible for femoral shaft fractures in children. Ann Chir Gynaecol 1991;80(4):392-5.

Moroz LA, Launay F, Kocher MS et al. Titanium elastic nailing of fractures of the femur in children. Predictors of complications and poor outcome. J Bone Joint Surg Br 2006 October;88(10):1361-6.

Nork SE, Hoffinger SA. Skeletal traction versus external fixation for pediatric femoral shaft fractures: a comparison of hospital costs and charges. J Orthop Trauma 1998 November;12(8):563-8.

Podeszwa DA, Mooney JF, III, Cramer KE, Mendelow MJ. Comparison of Pavlik harness application and immediate spica casting for femur fractures in infants. J Pediatr Orthop 2004 September;24(5):460-2.

Rasit AH, Mohammad AW, Pan KL. The pattern of femoral diaphyseal fractures in children admitted in Sarawak General Hospital. Med J Malaysia 2006 February;61 Suppl A:79-82.

Rasool MN, Govender S, Naidoo KS. Treatment of femoral shaft fractures in children by early spica casting. S Afr Med J 1989 August 5;76(3):96-9.

Rewers A, Hedegaard H, Lezotte D et al. Childhood femur fractures, associated injuries, and sociodemographic risk factors: a population-based study. Pediatrics 2005 May;115(5):e543-e552.

Ronchi L, Rosenbaum D, Athouel A et al. Femoral nerve blockade in children using bupivacaine. Anesthesiology 1989 April;70(4):622-4.

Song HR, Oh CW, Shin HD et al. Treatment of femoral shaft fractures in young children: comparison between conservative treatment and retrograde flexible nailing. J Pediatr Orthop B 2004 July;13(4):275-80.

Stannard JP, Christensen KP, Wilkins KE. Femur fractures in infants: a new therapeutic approach. J Pediatr Orthop 1995 July;15(4):461-6.

Sturdee SW, Templeton PA, Dahabreh Z, Cullen E, Giannoudis PV. Femoral fractures in children, is early interventional treatment beneficial? Injury 2007 August;38(8):937-44.

Wall EJ, Jain V, Vora V, Mehlman CT, Crawford AH. Complications of titanium and stainless steel elastic nail fixation of pediatric femoral fractures. J Bone Joint Surg Am 2008 June;90(6):1305-13.

Wolff CR, James P. The prevention of skin excoriation under children's hip spica casts using the goretex pantaloon. J Pediatr Orthop 1995 May;15(3):386-8.

Wright JG, Wang EE, Owen JL et al. Treatments for paediatric femoral fractures: a randomised trial. Lancet 2005 March 26;365(9465):1153-8

EXCLUDED ARTICLES FROM ORIGINAL SEARCH

Abbas D, Faisal M, Butt MS. Unreamed femoral nailing. Injury 2000 November;31(9):711-7.

Allen BL, Jr., Kant AP, Emery FE. Displaced fractures of the femoral diaphysis in children. Definitive treatment in a double spica cast. J Trauma 1977 January;17(1):8-19.

Allen BL, Jr., Schoch EP, III, Emery FE. Immediate spica cast system for femoral shaft fractures in infants and children. South Med J 1978 January;71(1):18-22.

Anglen JO, Choi L. Treatment options in pediatric femoral shaft fractures. J Orthop Trauma 2005 November;19(10):724-33.

Anwar IA, Battistella FD, Neiman R, Olson SA, Chapman MW, Moehring HD. Femur fractures and lung complications: a prospective randomized study of reaming. Clin Orthop Relat Res 2004;71-6.

Arneson TJ, Melton LJ, III, Lewallen DG, O'Fallon WM. Epidemiology of diaphyseal and distal femoral fractures in Rochester, Minnesota, 1965-1984. Clin Orthop Relat Res 1988 September;(234):188-94.

Aronson DD, Singer RM, Higgins RF. Skeletal traction for fractures of the femoral shaft in children. A long-term study. J Bone Joint Surg Am 1987 December;69(9):1435-9.

Bain GI, Zacest AC, Paterson DC, Middleton J, Pohl AP. Abduction strength following intramedullary nailing of the femur. J Orthop Trauma 1997;11:93-7.

Bar-On E, Sagiv S, Porat S. External fixation or flexible intramedullary nailing for femoral shaft fractures in children. A prospective, randomised study. J Bone Joint Surg Br 1997 November;79(6):975-8.

Barfod B, Christensen J. Fractures of the femoral shaft in children with special reference to subsequent overgrowth. Acta Chir Scand 1959 February 28;116(3):235-50.

Basumallick MN, Bandopadhyay A. Effect of dynamization in open interlocking nailing of femoral fractures. A prospective randomized comparative study of 50 cases with a 2- year follow-up. Acta Orthop Belg 2002 February;68(1):42-8.

Beals RK, Tufts E. Fractured femur in infancy: the role of child abuse. J Pediatr Orthop 1983 November;3(5):583-6.

Beaty JH, Austin SM, Warner WC, Canale ST, Nichols L. Interlocking intramedullary nailing of femoral-shaft fractures in adolescents: preliminary results and complications. J Pediatr Orthop 1994 March;14(2):178-83.

Berger P, De Graaf JS, Leemans R. The use of elastic intramedullary nailing in the stabilisation of paediatric fractures. Injury 2005 October;36(10):1217-20.

Blakemore LC, Loder RT, Hensinger RN. Role of intentional abuse in children 1 to 5 years old with isolated femoral shaft fractures. J Pediatr Orthop 1996 September;16(5):585-8.

Blasier RD, Aronson J, Tursky EA. External fixation of pediatric femur fractures. J Pediatr Orthop 1997 May;17(3):342-6.

Blichert-Toft M, Hammer A. Treatment of fractures of the femoral shaft. Acta Orthop Scand 1970;41(3):341-53.

Blumberg KD, Foster WC, Blumberg JF et al. A comparison of the Brooker-Wills and Russell-Taylor nails for treatment of patients who have fractures of the femoral shaft. The Journal of bone and joint surgery American volume 1990;72:1019-24.

Boman A, Gardell C, Janarv PM. Home traction of femoral shaft fractures in younger children. J Pediatr Orthop 1998 July;18(4):478-80.

Bourdelat D. Fracture of the femoral shaft in children: advantages of the descending medullary nailing. J Pediatr Orthop B 1996;5(2):110-4.

Bridgman S, Wilson R. Epidemiology of femoral fractures in children in the West Midlands region of England 1991 to 2001. J Bone Joint Surg Br 2004 November;86(8):1152-7.

Brouwer KJ, Molenaar JC, van LB. Rotational deformities after femoral shaft fractures in childhood. A retrospective study 27-32 years after the accident. Acta Orthop Scand 1981 February;52(1):81-9.

Brumback RJ, Wells JD, Lakatos R, Poka A, Bathon GH, Burgess AR. Heterotopic ossification about the hip after intramedullary nailing for fractures of the femur. J Bone Joint Surg Am 1990 August;72(7):1067-73.

Brumback RJ, Ellison TS, Poka A, Bathon GH, Burgess AR. Intramedullary nailing of femoral shaft fractures. Part III: Long-term effects of static interlocking fixation. J Bone Joint Surg Am 1992 January;74(1):106-12.

Bucholz RW, Jones A. Fractures of the shaft of the femur. J Bone Joint Surg Am 1991 December;73(10):1561-6.

Buckley SL. Current trends in the treatment of femoral shaft fractures in children and adolescents. Clin Orthop Relat Res 1997 May;(338):60-73.

Buehler KC, Thompson JD, Sponseller PD, Black BE, Buckley SL, Griffin PP. A prospective study of early spica casting outcomes in the treatment of femoral shaft fractures in children. J Pediatr Orthop 1995 January;15(1):30-5.

Bulut S, Bulut O, Tas F, Egilmez H. The measurement of the rotational deformities with computed tomography in femoral shaft fractures of the children treated with early spica cast. Eur J Radiol 2003 July;47(1):38-42.

Burwell HN. Fractures of the femoral shaft in children. Postgrad Med J 1969 September;45(527):617-21.

Burwell HN. Internal fixation in the treatment of fractures of the femoral shaft. Injury 1971 January;2(3):235-44.

Caglar O, Aksoy MC, Yazici M, Surat A. Comparison of compression plate and flexible intramedullary nail fixation in pediatric femoral shaft fractures. J Pediatr Orthop B 2006 May;15(3):210-4.

Caird MS, Mueller KA, Puryear A, Farley FA. Compression plating of pediatric femoral shaft fractures. J Pediatr Orthop 2003 July;23(4):448-52.

Cameron CD, Meek RN, Blachut PA, O'Brien PJ, Pate GC. Intramedullary nailing of the femoral shaft: a prospective, randomized study. J Orthop Trauma 1992;6(4):448-51.

Canadian Orthopaedic Trauma Society. Nonunion following intramedullary nailing of the femur with and without reaming. Results of a multicenter randomized clinical trial. The Journal of bone and joint surgery American volume 2003;85-A:2093-6.

Canadian Orthopaedic Trauma Society. Reamed versus unreamed intramedullary nailing of the femur: comparison of the rate of ARDS in multiple injured patients. J Orthop Trauma 2006;20:384-7.

Carey TP, Galpin RD. Flexible intramedullary nail fixation of pediatric femoral fractures. Clin Orthop Relat Res 1996 November;(332):110-8.

Casas J, Gonzalez-Moran G, Albinana J. Femoral fractures in children from 4 years to 10 years: conservative treatment. J Pediatr Orthop B 2001 January;10(1):56-62.

Celiker O, Cetin I, Sahlan S, Pestilci F, Altug M. Femoral shaft fractures in children: technique of immediate treatment with supracondylar Kirschner wires and one-and-a-half spica cast. J Pediatr Orthop 1988 September;8(5):580-4.

Chan KM, Tse PY, Chow YY, Leung PC. Closed medullary nailing for fractured shaft of the femur--a comparison between the Kuntscher and the AO techniques. Injury 1984 May;15(6):381-7.

Charash WE, Fabian TC, Croce MA. Delayed surgical fixation of femur fractures is a risk factor for pulmonary failure independent of thoracic trauma. J Trauma 1994 October;37(4):667-72.

Cheng JC, Cheung SS. Modified functional bracing in the ambulatory treatment of femoral shaft fractures in children. J Pediatr Orthop 1989 July;9(4):457-62.

Chitgopkar SD. Internal fixation of femoral shaft fractures in children by intramedullary Kirschner wires (a prospective study): its significance for developing countries. BMC Surg 2005;5:6.

Chu RS, Browne GJ, Cheng NG, Lam LT. Femoral nerve block for femoral shaft fractures in a paediatric Emergency Department: can it be done better? Eur J Emerg Med 2003 December;10(4):258-63.

Cigala F, Rega AN, Lotito FM. Growth disturbances following fractures of the femur and tibia in children. Ital J Orthop Traumatol 1985 March;11(1):121-5.

Clement DA, Colton CL. Overgrowth of the femur after fracture in childhood. An increased effect in boys. J Bone Joint Surg Br 1986 August;68(4):534-6.

Clinkscales CM, Peterson HA. Isolated closed diaphyseal fractures of the femur in children: comparison of effectiveness and cost of several treatment methods. Orthopedics 1997 December;20(12):1131-6.

Coyte PC, Bronskill SE, Hirji ZZ, igle-Takacs G, Trerise BS, Wright JG. Economic evaluation of 2 treatments for pediatric femoral shaft fractures. Clin Orthop Relat Res 1997 March;(336):205-15.

Czertak DJ, Hennrikus WL. The treatment of pediatric femur fractures with early 90-90 spica casting. J Pediatr Orthop 1999 March;19(2):229-32.

Damholt V, Zdravkovic D. Quadriceps function following fractures of the femoral shaft. Acta Orthop Scand 1972;43(2):148-56.

Damholt V, Zdravkovic D. Quadriceps function following fractures of the femoral shaft in children. Acta Orthop Scand 1974;45(5):756-63.

Danckwardt-Lilliestrom G. Intramedullary nailing of femoral shaft fractures after reaming of the medullary cavity. Report on a sex-year material. Acta Chir Scand 1973;139(2):155-66.

Davids JR. Rotational deformity and remodeling after fracture of the femur in children. Clin Orthop Relat Res 1994 May;(302):27-35.

Davis TJ, Topping RE, Blanco JS. External fixation of pediatric femoral fractures. Clin Orthop Relat Res 1995 September;(318):191-8.

Denton JS, Manning MP. Femoral nerve block for femoral shaft fractures in children: brief report. J Bone Joint Surg Br 1988 January;70(1):84.

Di Gennaro GL, Valdiserri L. Femoral shaft fractures during childhood. Chir Organi Mov 1999 October;84(4):299-307.

Dwyer AJ, Mam MK, John B, Gosselin RA. Femoral shaft fractures in children--a comparison of treatment. Int Orthop 2003;27(3):141-4.

Epps HR, Molenaar E, O'connor DP. Immediate single-leg spica cast for pediatric femoral diaphysis fractures. J Pediatr Orthop 2006 July;26(4):491-6.

Eriksson E, Wallin C. Immediate or delayed Kuntscher-rodding of femoral shaft fractures. Orthopedics 1986 February;9(2):201-4.

Esenyel CZ, Ozturk K, Adanir O, Aksoy B, Esenyel M, Kara AN. Skin traction in hip spica casting for femoral fractures in children. J Orthop Sci 2007 July;12(4):327-33.

Ferguson J, Nicol RO. Early spica treatment of pediatric femoral shaft fractures. J Pediatr Orthop 2000 March;20(2):189-92.

Finsen V, Svenningsen S, Harnes OB, Nesse O, Benum P. Osteopenia after plated and nailed femoral shaft fractures. J Orthop Trauma 1988;2(1):13-7.

Finsen V, Harnes OB, Nesse O, Benum P. Muscle function after plated and nailed femoral shaft fractures. Injury 1993 September;24(8):531-4.

Flynn JM, Hresko T, Reynolds RA, Blasier RD, Davidson R, Kasser J. Titanium elastic nails for pediatric femur fractures: a multicenter study of early results with analysis of complications. J Pediatr Orthop 2001 January;21(1):4-8.

Flynn JM, Luedtke L, Ganley TJ, Pill SG. Titanium elastic nails for pediatric femur fractures: lessons from the learning curve. Am J Orthop 2002 February;31(2):71-4.

Ford DJ, Hubbard MJ. Fractures of the femoral shaft. The advantages of internal fixation and problems after skeletal traction. J R Coll Surg Edinb 1987 December;32(6):368-70.

Fry K, Hoffer MM, Brink J. Femoral shaft fractures in brain-injured children. J Trauma 1976 May;16(5):371-3.

Fyodorov I, Sturm PF, Robertson WW, Jr. Compression-plate fixation of femoral shaft fractures in children aged 8 to 12 years. J Pediatr Orthop 1999 September;19(5):578-81.

Geist RW, Laros GS. Symposium. Rigid internal fixation of fractures. Femoral shaft fractures: editorial comment and comparative results. Clin Orthop Relat Res 1979 January;(138):5-9.

Giannoudis PV, Furlong AJ, MacDonald DA, Smith RM. Reamed against unreamed nailing of the femoral diaphysis: a retrospective study of healing time. Injury 1997 January;28(1):15-8.

Giannoudis PV, MacDonald DA, Matthews SJ, Smith RM, Furlong AJ, De BP. Nonunion of the femoral diaphysis. The influence of reaming and non-steroidal anti- inflammatory drugs. J Bone Joint Surg Br 2000 July;82(5):655-8.

Gogi N, Khan SA, Varshney MK. Limb length discrepancy following titanium elastic nailing in paediatric femoral shaft fractures. Acta Orthop Belg 2006 April;72(2):154-8.

Gogus A, Ozturk C, Tezer M, Camurdan K, Hamzaoglu A. "Sandwich technique" in the surgical treatment of primary complex fractures of the femur and humerus. Int Orthop 2007 February;31(1):87-92.

Gracilla RV, Diaz HM, Penaranda NR et al. Traction spica cast for femoral-shaft fractures in children. Int Orthop 2003;27(3):145-8.

Gregory P, Sullivan JA, Herndon WA. Adolescent femoral shaft fractures: rigid versus flexible nails. Orthopedics 1995 July;18(7):645-9.

Greisberg J, Bliss MJ, Eberson CP, Solga P, d'Amato C. Social and economic benefits of flexible intramedullary nails in the treatment of pediatric femoral shaft fractures... including discussion. Orthopedics 2002 October;25(10):1067-70.

Griffin PP, Green WT. Fractures of the shaft of the femur in children: treatment and results. Orthop Clin North Am 1972 March;3(1):213-24.

Gross RH, Davidson R, Sullivan JA, Peeples RE, Hufft R. Cast brace management of the femoral shaft fracture in children and young adults. J Pediatr Orthop 1983 November;3(5):572-82.

Gross RH, Stranger M. Causative factors responsible for femoral fractures in infants and young children. J Pediatr Orthop 1983 July;3(3):341-3.

Grossbard GD, Love BR. Femoral nerve block: a simple and safe method of instant analgesia for femoral shaft fractures in children. Aust N Z J Surg 1979 October;49(5):592-4.

Grover J, Wiss DA. A prospective study of fractures of the femoral shaft treated with a static, intramedullary, interlocking nail comparing one versus two distal screws. ORTHOP CLIN NORTH AM 1995;26(1):139-46.

Gupta RC, Varma AN, Mittal KK. Treatment of femoral diaphyseal fractures in children by strapping. Injury 1980 November;12(3):234-8.

Hagglund G, Hansson LI, Norman O. Correction by growth of rotational deformity after femoral fracture in children. Acta Orthop Scand 1983 December;54(6):858-61.

Haley CA, DeJong ES, Ward JA, Kragh JF, Jr. Waterproof versus cotton cast liners: a randomized, prospective comparison. Am J Orthop 2006 March;35(3):137-40.

Hansen TB. Fractures of the femoral shaft in children treated with an AO-compression plate. Report of 12 cases followed until adulthood. Acta Orthop Scand 1992 February;63(1):50-2.

Harper MC. Fractures of the femur treated by open and closed intramedullary nailing using the fluted rod. J Bone Joint Surg Am 1985 June;67(5):699-708.

Hedin H, Hjorth K, Larsson S, Nilsson S. Radiological outcome after external fixation of 97 femoral shaft fractures in children. Injury 2003 May;34(4):287-92.

Hedlund R, Lindgren U. The incidence of femoral shaft fractures in children and adolescents. J Pediatr Orthop 1986 January;6(1):47-50.

Heinrich SD, Drvaric DM, Darr K, MacEwen GD. The operative stabilization of pediatric diaphyseal femur fractures with flexible intramedullary nails: a prospective analysis. J Pediatr Orthop 1994 July;14(4):501-7.

Herscovici D, Jr., Scott DM, Behrens F, Nelson B, Benton J. The use of Ender nails in femoral shaft fractures: what are the remaining indications? J Orthop Trauma 1992;6(3):314-7.

Heyworth BE, Galano GJ, Vitale MA, Vitale MG. Management of closed femoral shaft fractures in children, ages 6 to 10: national practice patterns and emerging trends. J Pediatr Orthop 2004 September;24(5):455-9.

Holmes SJ, Sedgwick DM, Scobie WG. Domiciliary gallows traction for femoral shaft fractures in young children. Feasibility, safety and advantages. J Bone Joint Surg Br 1983 May;65(3):288-90.

Holst-Nielsen F. Dynamic intramedullary osteosynthesis in fractures of the femoral shaft. Acta Orthop Scand 1972;43(5):411-20.

Houshian S, Gothgen CB, Pedersen NW, Harving S. Femoral shaft fractures in children: elastic stable intramedullary nailing in 31 cases. Acta Orthop Scand 2004 June;75(3):249- 51.

Hull JB, Sanderson PL, Rickman M, Bell MJ, Saleh M. External fixation of children's fractures: use of the Orthofix Dynamic Axial Fixator. J Pediatr Orthop B 1997 July;6(3):203-6.

Humberger FW, Eyring EJ. Proximal tibial 90-90 traction in treatment of children with femoral-shaft fractures. J Bone Joint Surg Am 1969 April;51(3):499-504.

Infante AF, Jr., Albert MC, Jennings WB, Lehner JT. Immediate hip spica casting for femur fractures in pediatric patients. A review of 175 patients. Clin Orthop Relat Res 2000 July;(376):106-12.

Iqbal QM. Preliminary survey of aetiological factors in femoral shaft fractures. Med J Malaya 1970 September;25(1):25-8.

Iqbal QM. An appraisal of the treatment of femoral shaft fracture: open versus closed. Med J Aust 1976 March 20;1(12):392-5.

Irani RN, Nicholson JT, Chung SM. Long-term results in the treatment of femoral-shaft fractures in young children by immediate spica immobilization. J Bone Joint Surg Am 1976 October;58(7):945-51.

Jamaludin M. Femoral shaft fracture in children treated by early hip spica cast: early result of a prospective study. Med J Malaysia 1995 March;50(1):72-5.

Jeerathanyasakun Y, Hiranyavanitch P, Bhummichitra D, Sukswai P, Kovitvanitcha D, Thumkunanon V. Causes of femoral shaft fracture in children under five years of age. J Med Assoc Thai 2003 August;86 Suppl 3:S661-S666.

Johnson KD, Johnston DW, Parker B. Comminuted femoral-shaft fractures: treatment by roller traction, cerclage wires and an intramedullary nail, or an interlocking intramedullary nail. J Bone Joint Surg Am 1984 October;66(8):1222-35.

Kamal MH, Razak M, Ibrahim S, Lim A. Proximal third femoral shaft fractures in children: prevention of angular deformities using bilateral Thomas splints. Med J Malaysia 2000 September;55 Suppl C:68-73.

Kamdar BA, Arden GP. Intramedullary nailing for fractures of the femoral shaft. Injury 1974 August;6(1):7-12.

Kanlic EM, Anglen JO, Smith DG, Morgan SJ, Pesantez RF. Advantages of submuscular bridge plating for complex pediatric femur fractures. Clin Orthop Relat Res 2004 September;(426):244-51.

Kapukaya A, Subasi M, Necmioglu S, Arslan H, Kesemenli C, Yildirim K. Treatment of closed femoral diaphyseal fractures with external fixators in children. Arch Orthop Trauma Surg 1998;117(6-7):387-9.

Karaoglu S, Baktir A, Tuncel M, Karakas ES, Sakir TM. Closed Ender nailing of adolescent femoral shaft fractures. Injury 1994 October;25(8):501-6.

Karpos PA, McFerran MA, Johnson KD. Intramedullary nailing of acute femoral shaft fractures using manual traction without a fracture table. J Orthop Trauma 1995 February;9(1):57-62.

Kaufer H. Nonoperative ambulatory treatment for fracture of the shaft of the femur. Clin Orthop Relat Res 1972 September;87:192-9.

Kesemenli CC, Subasi M, Arslan H, Tuzuner T, Necmioglu S, Kapukaya A. Is External Fixation in Pediatric Femoral Fractures a Risk Factor for Refracture? J Pediatr Orthop 2004;24(1):17-20.

Kevau I, Watters DA. Conservative management of femoral shaft fractures. P N G Med J 1996 June;39(2):143-51.

Khan AQ, Sherwani MK, Agarwal S. Percutaneous K-wire fixation for femoral shaft fractures in children. Acta Orthop Belg 2006 April;72(2):164-9.

King J, Diefendorf D, Apthorp J, Negrete VF, Carlson M. Analysis of 429 fractures in 189 battered children. J Pediatr Orthop 1988 September;8(5):585-9.

Kirby RM, Winquist RA, Hansen ST, Jr. Femoral shaft fractures in adolescents: a comparison between traction plus cast treatment and closed intramedullary nailing. J Pediatr Orthop 1981;1(2):193-7.

Kissel EU, Miller ME. Closed Ender nailing of femur fractures in older children. J Trauma 1989 November;29(11):1585-8.

Kostuik JP, Harrington IJ. Treatment of infected un-united femoral shaft fractures. Clin Orthop Relat Res 1975 May;(108):90-4.

Kraus R, Schiefer U, Schafer C, Meyer C, Schnettler R. Elastic stable intramedullary nailing in pediatric femur and lower leg shaft fractures: intraoperative radiation load. J Pediatr Orthop 2008 January;28(1):14-6.

Kruse RW, Fracchia M, Boos M, Guille JT, Bowen JR. Goretex fabric as a cast underliner in children. J Pediatr Orthop 1991 November;11(6):786-7.

Lee YH, Lim KB, Gao GX et al. Traction and spica casting for closed femoral shaft fractures in children. J Orthop Surg (Hong Kong) 2007 April;15(1):37-40.

Lee ZL, Chang CH, Yang WE, Hung SS. Rush pin fixation versus traction and casting for femoral fracture in children older than seven years. Chang Gung Med J 2005 January;28(1):9-15.

Leet AI, Pichard CP, Ain MC. Surgical treatment of femoral fractures in obese children: does excessive body weight increase the rate of complications? J Bone Joint Surg Am 2005 December;87(12):2609-13.

Lepore L, Lepore S, Maffulli N. Intramedullary nailing of the femur with an inflatable self-locking nail: comparison with locked nailing. J Orthop Sci 2003;8(6):796-801.

Letts M, Jarvis J, Lawton L, Davidson D. Complications of rigid intramedullary rodding of femoral shaft fractures in children. J Trauma 2002 March;52(3):504-16.

Ligier JN, Metaizeau JP, Prevot J, Lascombes P. Elastic stable intramedullary nailing of femoral shaft fractures in children. J Bone Joint Surg Br 1988 January;70(1):74-7.

Lorenzi GL, Rossi P, Quaglia F, Parenti G, De GG, Pelilli E. Growth disturbances following fractures of the femur and tibia in children. Ital J Orthop Traumatol 1985 March;11(1):133-7.

Luhmann SJ, Schootman M, Schoenecker PL, Dobbs MB, Gordon JE. Complications of titanium elastic nails for pediatric femoral shaft fractures. J Pediatr Orthop 2003 July;23(4):443-7.

Malkawi H, Shannak A, Hadidi S. Remodeling after femoral shaft fractures in children treated by the modified blount method. J Pediatr Orthop 1986 July;6(4):421-9.

Mariotti JR, Mann RJ, Sarmiento A. Two-plate fixation of fractures of the femoral shaft. South Med J 1969 November;62(11):1353-8.

Maruenda-Paulino JI, Sanchis-Alfonso V, Gomar-Sancho F, rder-Prats A, Gasco-Gomez de MJ. Kuntscher nailing of femoral shaft fractures in children and adolescents. Int Orthop 1993;17(3):158-61.

Masse A, Bruno A, Bosetti M, Biasibetti A, Cannas M, Gallinaro P. Prevention of pin track infection in external fixation with silver coated pins: clinical and microbiological results. J Biomed Mater Res 2000 September;53(5):600-4.

Matsubara H, Yasutake H, Matsuda E, Uehara K, Niwada M, Tanzawa Y. Treatment of femoral shaft fractures in children using intramedullary Kirschner wire pinning. J Orthop Sci 2005;10(2):187-91.

McLaren AC, Roth JH, Wright C. Intramedullary rod fixation of femoral shaft fractures: comparison of open and closed insertion techniques. Can J Surg 1990 August;33(4):286- 90.

Mehlman CT, Bishai SK. Tibial nails for femoral shaft fractures in large adolescents with open femoral physes. J Trauma 2007 August;63(2):424-8.

Merickel J, Indeck W. Femoral shaft fractures in children. Minn Med 1973 May;56(5):377-81.

Miller ME, Bramlett KW, Kissell EU, Niemann KM. Improved treatment of femoral shaft fractures in children. The "pontoon" 90-90 spica cast. Clin Orthop Relat Res 1987 June;(219):140-6.

Miller R, Renwick SE, DeCoster TA, Shonnard P, Jabczenski F. Removal of intramedullary rods after femoral shaft fracture. J Orthop Trauma 1992;6(4):460-3.

Miner T, Carroll KL. Outcomes of external fixation of pediatric femoral shaft fractures. J Pediatr Orthop 2000 May;20(3):405-10.

Mohan K. The Kuentscher rod in the treatment of femoral shaft fractures. Int Surg 1971 June;55(6):431-4.

Mohan K. Fracture of the shaft of the femur in children. Int Surg 1975 May;60(5):282-4.

Momberger N, Stevens P, Smith J, Santora S, Scott S, Anderson J. Intramedullary nailing of femoral fractures in adolescents. J Pediatr Orthop 2000 July;20(4):482-4.

Morita S, Oda H. Surgical treatment of femur-shaft fractures in children. Nippon Geka Hokan 1967 September 1;36(5):627-36.

Moses T, Pan KL, Razak M. Conservative management of femoral shaft fractures in children. Med J Malaysia 1998 September;53 Suppl A:22-6.

Muckle DS, Siddiqi S. Ender's nails in femoral shaft fractures. Injury 1982 January;13(4):287-91.

Mutty CE, Jensen EJ, Manka MA, Jr., Anders MJ, Bone LB. Femoral nerve block for diaphyseal and distal femoral fractures in the emergency department. J Bone Joint Surg Am 2007 December;89(12):2599-603.

Nafei A, Teichert G, Mikkelsen SS, Hvid I. Femoral shaft fractures in children: an epidemiological study in a Danish urban population, 1977-86. J Pediatr Orthop 1992 July;12(4):499-502.

Narayanan UG, Hyman JE, Wainwright AM, Rang M, Alman BA. Complications of elastic stable intramedullary nail fixation of pediatric femoral fractures, and how to avoid them. J Pediatr Orthop 2004 July;24(4):363-9.

Neer CS, Cadman E. Treatment of fractures of the femoral shaft in children. J Am Med Assoc 1957 February 23;163(8):634-7.

Norman D, Peskin B, Ehrenraich A, Rosenberg N, Bar-Joseph G, Bialik V. The use of external fixators in the immobilization of pediatric fractures. Arch Orthop Trauma Surg 2002 September;122(7):379-82.

O'Donnell TM, Murphy DP, Mullett H, Moore DP, Fogarty EE, Dowling FE. Treatment of femoral shaft fractures in children using the "Tobruk" method. Am J Orthop 2006 August;35(8):356-61.

Ogunlade SO, Omololu AB, Alonge TO, Salawu SA. Domiciliary treatment of femoral shaft fracture in children. West Afr J Med 2003 January;22(1):67-71.

Oh CW, Park BC, Kim PT, Kyung HS, Kim SJ, Ihn JC. Retrograde flexible intramedullary nailing in children's femoral fractures. Int Orthop 2002;26(1):52-5.

Ostrum RF, Agarwal A, Lakatos R, Poka A. Prospective comparison of retrograde and antegrade femoral intramedullary nailing. J Orthop Trauma 2000;14:496-501.

Pahud B, Vasey H. Delayed internal fixation of femoral shaft fractures--is there an advantage? A review of 320 fractures. J Bone Joint Surg Br 1987 May;69(3):391-4.

Pandy S. Nailing and immediate weight bearing in femoral shaft fractures. Int Surg 1973 October;58(10):712-5.

Parrini L, Paleari M, Biggi F. Growth disturbances following fractures of the femur and tibia in children. Ital J Orthop Traumatol 1985 March;11(1):139-45.

Parvinen T, Viljanto J, Paananen M, Vilkki P. Torsion deformity after femoral fracture in children. A follow-up study. Ann Chir Gynaecol Fenn 1973;62(1):25-9.

Powell HD. Domiciliary gallows traction for femoral shaft fractures in young children. Br Med J 1972 July 8;3(5818):108.

Puttaswamaiah R, Chandran P, Sen R, Kataria S, Gill SS. Deformities in conservatively treated closed fractures of the shaft of the femur in children. Acta Orthop Belg 2006 April;72(2):147-53.

Rascher JJ, Nahigian SH, Macys JR, Brown JE. Closed nailing of femoral-shaft fractures. J Bone Joint Surg Am 1972 April;54(3):534-44.

Rathjen KE, Riccio AI, De La GD. Stainless steel flexible intramedullary fixation of unstable femoral shaft fractures in children. J Pediatr Orthop 2007 June;27(4):432-41.

Reeves RB, Ballard RI, Hughes JL. Internal fixation versus traction and casting of adolescent femoral shaft fractures. J Pediatr Orthop 1990 September;10(5):592-5.

Reis ND, Aginsky J. A double compression medullary nail: preliminary report of an early clinical trial. Injury 1980 February;11(3):197-202.

Ricci WM, Devinney S, Haidukewych G, Herscovici D, Sanders R. Trochanteric nail insertion for the treatment of femoral shaft fractures. J Orthop Trauma 2005 September;19(8):511-7.

Ricci WM, Schwappach J, Tucker M et al. Trochanteric versus piriformis entry portal for the treatment of femoral shaft fractures. J Orthop Trauma 2006 November;20(10):663-7.

Robertson CR. Fractured shaft of femur. Cent Afr J Med 1968 May;14(5):97-103.

Rokkanen P, Slatis P, Vanka E. Closed or open intramedullary nailing of femoral shaft fractures? A comparison with conservatively treated cases. J Bone Joint Surg Br 1969 May;51(2):313-23.

Roser LA. Initial spica cast for femoral shaft fractures in children. Northwest Med 1969 November;68(11):1012-5.

Rush J. The Kuntscher rod in the treatment of femoral shaft fractures: the question of early versus delayed operation. Aust N Z J Surg 1970 August;40(1):44-52.

Ryan JR. 90-90 skeletal femoral traction for femoral shaft fractures in children. J Trauma 1981 January;21(1):46-8.

Sahin V, Baktir A, Turk CY, Karakas ES, Aktas S. Femoral shaft fractures in children treated by closed reduction and early spica cast with incorporated supracondylar Kirschner wires: a long-term follow-up results. Injury 1999 March;30(2):121-8.

Salem KH, Lindemann I, Keppler P. Flexible intramedullary nailing in pediatric lower limb fractures. J Pediatr Orthop 2006 July;26(4):505-9.

Sarmiento A. Functional bracing of tibial and femoral shaft fractures. Clin Orthop Relat Res 1972 January;82:2-13.

Savastano AA, Cadena E. A comparative study of the treatment of fractures of the shaft of the femur by traction and open fixation. Traction indicated for patients under sixteen, with intramedullary nailing reserved for patients over twenty-two. R I Med J 1971 March;54(3):144-6.

Scheerder FJM, Schnater JM, Sleeboom C, Aronson DC. Bryant traction in paediatric femoral shaft fractures, home traction versus hospitalisation. Injury 2008;39(4):456-62.

Schonk JW. Comparative follow-up study of conservative and surgical treatment of femoral shaft fractures in children. Arch Chir Neerl 1978;30(4):231-8.

Schranz PJ, Gultekin C, Colton CL. External fixation of fractures in children. Injury 1992;23(2):80-2.

Scott J, Wardlaw D, McLauchlan J. Cast bracing of femoral shaft fractures in children: a preliminary report. J Pediatr Orthop 1981;1(2):199-201.

Scully TJ. Ambulant, nonoperative management of femoral shaft fractures. I. Clin Orthop Relat Res 1974 May;(100):195-203.

Selesnick H, Griffiths G. A waterproof cast liner earns high marks. PHYS SPORTSMED 1997;25(9):67-74.

Shannon EG, DiFazio R, Kasser J, Karlin L, Gerbino P. Waterproof casts for immobilization of children's fractures and sprains. J Pediatr Orthop 2005 January;25(1):56-9.

Shepherd LE, Shean CJ, Gelalis ID, Lee J, Carter VS. Prospective randomized study of reamed versus unreamed femoral intramedullary nailing: an assessment of procedures. J Orthop Trauma 2001 January;15(1):28-32.

Shih HN, Chen LM, Lee ZL, Shih CH. Treatment of femoral shaft fractures with the Hoffmann external fixator in prepuberty. J Trauma 1989 April;29(4):498-501.

Shih JS, Chen WT. Closed vs open nailing in the treatment of femoral shaft fractures. Taiwan Yi Xue Hui Za Zhi 1981 July;80(7):732-9.

Sia S, Pelusio F, Barbagli R, Rivituso C. Analgesia before performing a spinal block in the sitting position in patients with femoral shaft fracture: a comparison between femoral nerve block and intravenous fentanyl. Anesth Analg 2004;99:1221-4, table.

Siegmeth A, Wruhs O, Vecsei V. External fixation of lower limb fractures in children. Eur J Pediatr Surg 1998 February;8(1):35-41.

Sink EL, Gralla J, Repine M. Complications of pediatric femur fractures treated with titanium elastic nails: a comparison of fracture types. J Pediatr Orthop 2005 September;25(5):577-80.

Sink EL, Hedequist D, Morgan SJ, Hresko T. Results and technique of unstable pediatric femoral fractures treated with submuscular bridge plating. J Pediatr Orthop 2006 March;26(2):177-81.

Skak SV, Jensen TT. Femoral shaft fracture in 265 children. Log-normal correlation with age of speed of healing. Acta Orthop Scand 1988 December;59(6):704-7.

Skak SV, Overgaard S, Nielsen JD, Andersen A, Nielsen ST. Internal fixation of femoral shaft fractures in children and adolescents: a ten- to twenty-one-year follow-up of 52 fractures. J Pediatr Orthop B 1996;5(3):195-9.

Sletten R, Gustilo RB, Miller D, Hamel A, Kleven L. 148 femoral shaft fractures in 144 patients. An analysis. Minn Med 1971 April;54(4):261-4.

Smason JB. Fractures of the femoral shaft. Med Trial Tech Q 1967 March;13(3):1-9.

Snowdowne RB. Fractures of the femoral shaft--an ambulatory method of treatment. S Afr J Surg 1973 December;11(4):281-5.

Sola J, Schoenecker PL, Gordon JE. External fixation of femoral shaft fractures in children: enhanced stability with the use of an auxiliary pin. J Pediatr Orthop 1999 September;19(5):587-91.

Spinner M, Freundlich BD, Miller IJ. Double-spica technic for primary treatment of fractures of the shaft of the femur in children and adolescents. Clin Orthop Relat Res 1967 July;53:109-14.

Staheli LT. Femoral and tibial growth following femoral shaft fracture in childhood. Clin Orthop Relat Res 1967 November;55:159-63.

Staheli LT, Sheridan GW. Early spica cast management of femoral shaft fractures in young children. A technique utilizing bilateral fixed skin traction. Clin Orthop Relat Res 1977 July;(126):162-6.

Stans AA, Morrissy RT, Renwick SE. Femoral shaft fracture treatment in patients age 6 to 16 years. J Pediatr Orthop 1999 March;19(2):222-8.

Stella J, Ellis R, Sprivulis P. Nerve stimulator-assisted femoral nerve block in the emergency department. Emerg Med 2000;12(4):322-5.

Stilli S, Magnani M, Lampasi M, Antonioli D, Bettuzzi C, Donzelli O. Remodelling and overgrowth after conservative treatment for femoral and tibial shaft fractures in children. Chir Organi Mov 2008 January;91(1):13-9.

Sudmann E. Rotational displacement after percutaneous, intramedullary osteosynthesis of femur shaft fractures. Acta Orthop Scand 1973;44(2):242-8.

Sugi M, Cole WG. Early plaster treatment for fractures of the femoral shaft in childhood. J Bone Joint Surg Br 1987 November;69(5):743-5.

Suiter RD, Bianco AJ, Jr. Fractures of the femoral shaft. J Trauma 1971 March;11(3):238-47.

Taitz J, Moran K, O'Meara M. Long bone fractures in children under 3 years of age: is abuse being missed in Emergency Department presentations? J Paediatr Child Health 2004 April;40(4):170-4. ten Duis HJ, Nijsten MW, Klasen HJ, Binnendijk B. Fat embolism in patients with an isolated fracture of the femoral shaft. J Trauma 1988 March;28(3):383-90.

Thompson JD, Buehler KC, Sponseller PD et al. Shortening in femoral shaft fractures in children treated with spica cast. Clin Orthop Relat Res 1997 May;(338):74-8.

Tigani D, Fravisini M, Stagni C, Pascarella R, Boriani S. Interlocking nail for femoral shaft fractures: is dynamization always necessary? Int Orthop 2005 April;29(2):101-4.

Till H, Huttl B, Knorr P, Dietz HG. Elastic stable intramedullary nailing (ESIN) provides good long-term results in pediatric long-bone fractures. Eur J Pediatr Surg 2000 October;10(5):319-22.

Timmerman LA, Rab GT. Intramedullary nailing of femoral shaft fractures in adolescents. J Orthop Trauma 1993;7(4):331-7.

Tondare AS, Nadkarni AV. Femoral nerve block for fractured shaft of femur. Can Anaesth Soc J 1982 May;29(3):270-1.

Tornetta IP, Tiburzi D. Antegrade or retrograde reamed femoral nailing. Journal of Bone & Joint Surgery British Volume 2000;82:652-4.

Tornetta P, Tiburzi D. The treatment of femoral shaft fractures using intramedullary interlocked nails with and without intramedullary reaming: a preliminary report. J Orthop Trauma 1997;11:89-92.

Tortolani PJ, Ain MC, Miller NH, Brumback RJ, Sponseller PD. Tibial nails for femoral shaft fractures in adolescents: "off-label" usage. Orthopedics 2001 June;24(6):553-7.

Townsend DR, Hoffinger S. Intramedullary nailing of femoral shaft fractures in children via the trochanter tip. Clin Orthop Relat Res 2000 July;(376):113-8.

Tucker MC, Schwappach JR, Leighton RK, Coupe K, Ricci WM. Results of femoral intramedullary nailing in patients who are obese versus those who are not obese: a prospective multicenter comparison study. J Orthop Trauma 2007 September;21(8):523- 9. van Niekerk JL, ten Duis HJ, Binnendijk B, Schoots FJ, Goris RJ. Duration of fracture healing after early versus delayed internal fixation of fractures of the femoral shaft. Injury 1987 March;18(2):120-2. van Niekerk JL, Schoots FJ. Femoral shaft fractures treated with plate fixation and interlocked nailing: a comparative retrospective study. Injury 1992;23(4):219-22. van Tets WF, Van der WC. External fixation for diaphyseal femoral fractures: a benefit to the young child? Injury 1992;23(3):162-4.

Verbeek HO. Does rotation deformity, following femur shaft fracture, correct during growth? Reconstr Surg Traumatol 1979;17:75-81.

Vijaya S. Treatment of fracture of the shaft of the femur in the newborn. J Singapore Paediatr Soc 1966 October;8(2):66-70.

Viljanto J, Paananen M. Return to work after femoral shaft fracture. Ann Chir Gynaecol Fenn 1973;62(1):30-5.

Viljanto J, Linna MI, Kiviluoto H, Paananen M. Indications and results of operative treatment of femoral shaft fractures in children. Acta Chir Scand 1975;141(5):366-9.

Walsh MG. Limb lengths following femoral shaft fracture in children. J Ir Med Assoc 1973 August 25;66(16):447-53.

Ward WT, Levy J, Kaye A. Compression plating for child and adolescent femur fractures. J Pediatr Orthop 1992 September;12(5):626-32.

Wathen JE, Gao D, Merritt G, Georgopoulos G, Battan FK. A randomized controlled trial comparing a fascia iliaca compartment nerve block to a traditional systemic analgesic for femur fractures in a pediatric emergency department. Ann Emerg Med 2007 Aug;50(2):162-71.

Webb LX, Gristina AG, Fowler HL. Unstable femoral shaft fractures: a comparison of interlocking nailing versus traction and casting methods. J Orthop Trauma 1988;2(1):10- 2.

Weinberg AM, Hasler CC, Leitner A, Lampert C, Von Laer L. External fixation of pediatric femoral shaft fractures. Treatment and results of 121 fractures. Eur J Trauma 2000;26(1):25-32.

Wilber MC, Evans EB. Fractures of the femoral shaft treated surgically. Comparative results of early and delayed operative stabilization. J Bone Joint Surg Am 1978 June;60(4):489-91.

Wilson NC, Stott NS. Paediatric femoral fractures: factors influencing length of stay and readmission rate. Injury 2007 August;38(8):931-6.

Wong J, Boyd R, Keenan NW et al. Gait patterns after fracture of the femoral shaft in children, managed by external fixation or early hip spica cast. J Pediatr Orthop 2004 September;24(5):463-71.

Wong PC. An epidemiological appraisal of femoral shaft fractures in a mixed Asian population--Singapore. Singapore Med J 1967 December;7(4):236-9.

Wu C. Exchange nailing for aseptic nonunion of femoral shaft: a retrospective cohort study for effect of reaming size. J TRAUMA 2007 October;63(4):859-65.

Wu CC, Shih CH, Ueng WN, Chen YJ. Treatment of segmental femoral shaft fractures. Clin Orthop Relat Res 1993 February;(287):224-30.

Wu CC, Shih CH, Chen WJ, Tai CL. Treatment of ununited femoral shaft fractures associated with locked nail breakage: comparison between closed and open revision techniques. J Orthop Trauma 1999 September;13(7):494-500.

Yamaji T, Ando K, Nakamura T, Washimi O, Terada N, Yamada H. Femoral shaft fracture callus formation after intramedullary nailing: a comparison of interlocking and Ender nailing. J Orthop Sci 2002;7(4):472-6.

Yandow SM, Archibeck MJ, Stevens PM, Shultz R. Femoral-shaft fractures in children: a comparison of immediate casting and traction. J Pediatr Orthop 1999 January;19(1):55- 9.

Yu CK, Singh VA, Mariapan S, Chong STB. Antegrade versus retrograde locked intramedullary nailing for femoral fractures: which is better? European Journal of Trauma and Emergency Surgery 2007 April;33(2):135-40.

Ziv I, Blackburn N, Rang M. Femoral intramedullary nailing in the growing child. J Trauma 1984 May;24(5):432-4.

Zlowodzki M, Bhandari M, Marek DJ, Cole PA, Kregor PJ. Operative treatment of acute distal femur fractures: systematic review of 2 comparative studies and 45 case series (1989 to 2005). J Orthop Trauma 2006 May;20(5):366-71.

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Zlowodzki M, Vogt D, Cole PA, Kregor PJ. Plating of femoral shaft fractures: Open reduction and internal fixation versus submuscular fixation. J Trauma Inj Infect Crit Care 2007;63(5):1061-5.

EXCLUDED ARTICLES FROM UPDATED SEARCH Leu,D.; Sargent,M.C.; Ain,M.C.; Leet,A.I.; Tis,J.E.; Sponseller,P.D. Spica casting for pediatric femoral fractures: a prospective, randomized controlled study of single-leg versus double-leg spica casts. Journal of Bone and Joint Surgery, 2012; 94(14): 1259- 1264

Kumar,S.; Roy,S.K.; Jha,A.K.; Chatterjee,D.; Banerjee,D.; Garg,A.K. An evaluation of flexible intramedullary nail fixation in femoral shaft fractures in paediatric age group. Journal of the Indian Medical Association, 2011; 109 (6): 416-7

Vanlaningham,C.J.; Schaller,T.M.; Wise,C. Skeletal versus skin traction before definitive management of pediatric femur fractures: a comparison of patient narcotic requirements. Journal of Pediatric Orthopaedics 2009; 29 (6): 609-611

Park,K.C.; Oh,C.W.; Byun,Y.S.; Oh,J.K.; Lee,H.J.; Park,K.H.; Kyung,H.S.; Park,B.C. Intramedullary nailing versus submuscular plating in adolescent femoral fracture. Journal of Injury 2012; 43 (6): 870-875

Flynn,J.M.; Garner,M.R.; Jones,K.J.; D'Italia,J.; Davidson,R.S.; Ganley,T.J.; Horn,B.D.; Spiegel,D.; Wells,L. The treatment of low-energy femoral shaft fractures: a prospective study comparing the walking spica with the traditional spica cast. Journal of Bone and Joint Science, 2011; 93 (23): 2196-2202

Altay,M.A.; Erturk,C.; Cece,H.; Isikan,U.E. Mini-open versus closed reduction in titanium elastic nailing of paediatric femoral shaft fractures: a comparative study. Acta Orthopaedics Belgica, 2011; 77 (2), 211-217

Garner,M.R.; Bhat,S.B.; Khujanazarov,I.; Flynn,J.M.; Spiegel,D. Fixation of length- stable femoral shaft fractures in heavier children: flexible nails vs rigid locked nails. Journal of Pediatric Orthopaedics, 2011; 31 (1), 11-16

Assaghir,Y. The safety of titanium elastic nailing in preschool femur fractures: A retrospective comparative study with spica cast. Journal of Pediatric Orthopaedics, 2013. 22 (4), 289-295

Nascimento,F.P.; Santili,C.; Akkari,M.; Waisberg,G.; Braga,S.R.; Fucs,P.M.M.B. Flexible intramedullary nails with traction versus plaster cast for treating femoral shaft fractures in children: Comparative retrospective study. Sao Paulo Medical Journal, 2013; 131 (1), 5-13

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APPENDIX XI

INCONCLUSIVE RECOMMENDATIONS REMOVED FROM UPDATED GUIDELINE

The recommendations listed below were published in the original 2009 guideline, but removed from the 2015 reissue due to a lack of evidence.

 We are unable to recommend for or against early spica casting for children age six months to five years with a diaphyseal femur fracture with greater than 2 cm of shortening.

 We are unable to recommend for or against patient weight as a criterion for the use of spica casting in children age six months to five years with a diaphyseal femur fracture.

 We are unable to recommend for or against using any specific degree of angulation or rotation as a criterion for altering the treatment plan when using the spica cast in children six months to five years of age.

 We are unable to recommend for or against removal of surgical implants from asymptomatic patients after treatment of diaphyseal femur fractures.

 We are unable to recommend for or against outpatient physical therapy to improve function after treatment pediatric diaphyseal femur fractures.

 We are unable to recommend for or against the use of locked versus non-locked plates for fixation of pediatric femur fractures.

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